EndometriosisPhase 2QLARITYNCT03749109
Quinagolide Vaginal Ring on Lesion Reduction Assessed by MRI in Women With Endometriosis/Adenomyosis
A Phase 2 study testing Quinagolide 1080 µg in people with Endometriosis, run by Ferring Pharmaceuticals at 11 sites in 4 countries.
Trial summary
This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Quinagolide 1080 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 19 Aug 2019to 18 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
- Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
- Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
- Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
- Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
- Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices (except for tampons) from randomization to the end of treatment
Who cannot join
- Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
- Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
- Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
- Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
- Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Italy4 sites
Azienda Opsedaliera Universitaria Careggi
Florence
Università degli Studi di Roma La Sapienza
Rome
Azienda Ospedaliera Universitaria Senese
Siena
Azienda Ospedaliera Universitaria Integrata Verona
Verona
Germany3 sites
Charité Universitätsmedizin
Berlin
Universitätsklinikum Carl Gustav Carus
Dresden
Universitätsklinikum Münster
Münster
Poland3 sites
Centrum Medyczne PROMED
Krakow
Gabinet Lekarski Specjalistyczny SONUS
Warsaw
Specjalistyczny Gabinet Lekarski
Warsaw
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis
This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.
- Conditions
- Endometriosis
- Being tested
- Quinagolide 1080 µg, Placebo
- Keywords
- Endometrioma, Adenomyosis, Deep infiltrating endometriosis
- Medical subject headings
- Endometriosis, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quinagolide 1080 µgDrug
Also called FE 999051
Vaginal ring containing Quinagolide 1080 µg for daily releases
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Quinagolide 1080 µg | Experimental | Vaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. Receives: Drug: Quinagolide 1080 µg |
| Placebo | Placebo comparator | Vaginal ring containing matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Secondary outcomes (45)
Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4.
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
Transvaginal ultrasound (TVU) will be performed, preferably by the same sonographer, at the screening visit and at end-of-treatment / cycle 4.
Measured: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
B\&B scale is a used scale for endometriosis that consists of two parts, with the first part evaluating symptoms (i.e. different types of pain) and the second part evaluating physical signs.
In the first part, the subject was asked to grade her pelvic pain (item A), dysmenorrhea (item B) and dyspareunia (item C) during the last menstrual cycle as none, mild, moderate or severe, corresponding to a score of 0-3.
In the second part, the investigator graded the subject's pelvic tenderness (item D) and induration (item E) based on findings from a pelvic examination as none, mild, moderate or severe, corresponding to a score of 0-3.
The total symptom and sign severity score was the sum of all five scores, i.e. A+B+C+D+E.
The score can be between 0 and 15.
Measured: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
Assessed by Subjects. NRS is a 11-point scale, with 0 indicating no pain and 10 indicating the worst imaginable pain.
Subjects were asked to score the worst pain in relation to endometriosis / adenomyosis on the NRS based on a recall of their experiences during the following timeframes:
- during the last menstrual cycle
- during the menstrual period of the last menstrual cycle
- during the non-menstrual period of the last menstrual cycle
Measured: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
EHP-30 is a quality-of-life questionnaire. Score ranges from 0-100 and lower score denotes improvement.
It consists of 30 questions measuring the frequency of the endometriosis impact on their quality of life during the past four weeks, with five options of never, rarely, sometimes, often and always.
Measured: At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Cycle Duration is shown.
Measured: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
Assessed by subject self-reported answers to menstrual bleeding questions. The Menstrual Bleeding Duration is shown.
Measured: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Measured: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Measured: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
Assessed by blood sample collection
Measured: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
Assessed by blood sample collection
Measured: Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Platelets
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Albumin
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Calcium
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Chloride
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Creatinine
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Glucose
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Phosphate
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Potassium
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Sodium
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Protein
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Urate
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Urea Nitrogen
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Proportion of Subjects With Markedly Abnormal Changes in Clinical Chemistry and Hematology Parameters
Assessed by blood sample collection
Measured: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Frequency and Intensity of Adverse Events
Assessed by and Adverse Event Log completed by the Investigator
Measured: From obtaining the informed consent to end of trial (up to 6 menstrual cycles ~ around 6 months, each cycle is approximately 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start19 Aug 2019
- Primary completion21 Jun 2021
- Study completion18 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749109
- Sponsor's protocol ID
- 000295
- Acronym
- QLARITY
- Status last verified
- Aug 2023
- First submitted
- 19 Nov 2018
- Last updated
- 7 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pellicer A, Taylor HS, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta KE, Pinton P, Heiser PW, Bagger YZ. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113946. doi: 10.1016/j.ejogrb.2025.113946. Epub 2025 Mar 30.
PubMed 40188683
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Proof-of-mechanism Phase 2 Trial Investigating the Effect of Quinagolide Extended-release Vaginal Ring on Reduction of Lesions Assessed by High-resolution Magnetic Resonance Imaging in Women With Endometrioma, Deep Infiltrating Endometriosis, and/or Adenomyosis
- ClinicalTrials.gov ID
- NCT03749109
- Acronym / sponsor ID
- QLARITY / 000295
- Conditions
- Endometriosis
- Keywords
- Endometrioma, Adenomyosis, Deep infiltrating endometriosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 18 Jul 2021 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Posted 7 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized, double-blind, placebo-controlled, proof-of-mechanism phase 2 trial investigating the effect of quinagolide extended-release vaginal ring on reduction of lesions assessed by high-resolution magnetic resonance imaging in women with endometrioma, deep infiltrating endometriosis, and/or adenomyosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quinagolide 1080 µg | Experimental | Drug: Quinagolide 1080 µgVaginal ring containing Quinagolide 1080 µg, with daily target release rate of 13.5 µg. |
| Placebo | Placebo comparator | Drug: PlaceboVaginal ring containing matching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pre-menopausal women between the ages 18-45 years (both inclusive) at the time of signing the informed consent
- Body mass index (BMI) of 18-35 kg/m2 (both inclusive) at screening
- Confirmation of deep infiltrating endometriosis (DIE), endometrioma or adenomyosis by high-resolution MRI at screening
- Transvaginal ultrasound (TVU) documenting a uterus with no abnormalities of endometrium and presence of at least one ovary with no clinically significant abnormalities at screening. Note that presence of uterine fibroids are not exclusionary but presence of any submucosal fibroids or polyps are exclusionary
- Willing and able to use a non-hormonal single-barrier method (i.e. condom) for contraception from the start of screening to the end-of-treatment. This is not required if adequate contraception is achieved by vasectomy of the male sexual partner, surgical sterilisation (e.g. tubal ligation and blockage methods such as ESSURE) of the subject, or true abstinence of the subject (sporadic sexual intercourse with men requiring condom use)
Key exclusion criteria (5 listed)
- Use of depot medroxyprogesterone acetate (MPA) within 10 months prior to the screening visit.
- Use of gonadotropin-releasing (GnRH) agonists (3-month depot) or dopamine agonists within 6 months prior to the screening visit.
- Use of GnRH agonists (1-month depot or nasal spray), GnRH antagonists, aromatase inhibitors, danazol, birth control implants (e.g. NEXPLANON), progestogen or levonorgestrel releasing intrauterine device (IUD) within 3 months prior to the screening visit.
- Use of hormonal contraceptives (including combined oral contraceptive pill, transdermal patch, and contraceptive ring) within 1 menstrual cycle prior to the screening visit.
- Contraindications to MRI such as having internal/external metallic devices and/or accessories (e.g. cardiac pacemakers and leg braces)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quinagolide 1080 µgAlso: FE 999051Vaginal ring containing Quinagolide 1080 µg for daily releases | Drug | Quinagolide 1080 µg |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
The MRI examination was performed on a high resolution 3T machine at screening and at end-of-treatment / cycle 4. At screening, every measurable lesion (defined as ≥10 mm in size) of any type was recorded and was summed up by type for primary analysis.
45 secondary outcomes
Percentage of Changes in the Sizes of Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Proportion of Lesions by Type With a Decrease in a Size of ≥5 mm on MR Images at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Proportion of Subjects With a Lesion of Any Type Decreased in a Size of ≥5 mm on MR Images at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Number of New or Disappearing Endometrioma, DIE and Adenomyosis Lesions Summed by Type on MR Images at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in the Volumes (mm3) of Endometrioma and DIE Lesions Summed by Type on MR Images at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in the Sizes of Endometrioma Assessed by Transvaginal Ultrasound (TVU) at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Changes in the Mean Individual and Total Symptom and Sign Severity of Scores of the Biberoglu and Behrman (B&B) Scale at Cycle 4
Time frame: At baseline and at menstrual cycle 4 (around 4 months, each cycle is approximately 28 days)
Changes in the Numerical Rating Scale (NRS) Pain Scores Per Cycle at Cycles 1, 2, 3 and 4
Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Changes in the Endometriosis Health Profile-30 (EHP-30) Scores at Cycles 2 and 4
Time frame: At baseline, at menstrual cycles 2 (~2 months) and 4 (~4 months)
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Cycle Duration)
Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Changes in the Menstrual Bleeding Pattern Over 4 Cycles (Menstrual Bleeding Duration)
Time frame: At baseline and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Serum Levels of Prolactin During Cycle 1, at Cycles 2 and 4
Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Serum Levels of Thyroid-stimulating Hormone (TSH) During Cycle 1, at Cycles 2 and 4
Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Serum Levels of Insulin-like Growth Factor-1 (IGF-1) During Cycle 1, at Cycles 2 and 4
Time frame: Within 1-5 days post randomization, and at menstrual cycles 2 (~2 months) and 4 (~4 months)
Plasma Concentrations of Quinagolide and Its Metabolites During Cycles 1 to 4
Time frame: Within 1-5 days post randomization, within 7-14 days post randomization, and at menstrual cycles 1 (~1 month), 2 (~2 months), 3 (~3 months) and 4 (~4 months)
Changes in Clinical Chemistry and Hematology Parameters: Hematocrit
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Hemaglobin
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Hemoglobin
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular HGB Concentration
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Ery. Mean Corpuscular Volume
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Platelets
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Erythrocytes
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Leukocytes
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Alanine Aminotransferase
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Albumin
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Alkaline Phosphatase
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Aspartate Aminotransferase
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Bicarbonate
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Direct Bilirubin
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Bilirubin
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Calcium
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Chloride
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Cholesterol
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Creatinine
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Gamma Glutamyl Transferase
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Glucose
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Lactate Dehydrogenase
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Phosphate
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Potassium
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Changes in Clinical Chemistry and Hematology Parameters: Sodium
Time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40188683Pellicer A, Taylor HS, Alberich-Bayarri A, Liu Y, Gamborg M, Barletta KE, Pinton P, Heiser PW, Bagger YZ. Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113946. doi: 10.1016/j.ejogrb.2025.113946. Epub 2025 Mar 30.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quinagolide 1080 µg in people with Endometriosis, run by Ferring Pharmaceuticals at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy, Germany, Poland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Sizes (mm) of Endometrioma, Deep Infiltrating Endometriosis (DIE) and Adenomyosis Lesions Summed by Type on Magnetic Resonance (MR) Images at Cycle 4 (time frame: At baseline and at menstrual cycle 4 (around 5 months, each cycle is approximately 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.