Uterine FibroidsPhase 2NCT00776074
A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.
A Phase 2 study testing Leuprorelin (GF) and Leuprorelin (GC) in people with Uterine Fibroids, run by Takeda.
Trial summary
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- Leuprorelin (GF) and Leuprorelin (GC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with measurable uterine fibroids confirmed by vaginal or abdominal ultrasound, deemed otherwise healthy.
- A body mass index in the range 18 to 28.
- Oestradiol, progesterone, luteinizing hormone and follicle stimulating hormone results within the range of normal ovarian function.
- Regular menstruation (except for symptoms of fibroids).
- Females of childbearing potential who are sexually active must agree to use barrier contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Who cannot join
- Acute pelvioperitonitis, ovarian cysts, persistent corpus luteum.
- History of bilateral oophorectomy, hysterectomy, or hypophysectomy.
- Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the patient.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the patient participation in the study or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
- Presence or history of severe adverse reaction to any drug.
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- Participation in other clinical studies of a new chemical entity or a prescription medicine within the previous 3 months.
- Presence or history of drug or alcohol abuse, or smoking of more than 10 cigarettes daily.
- Evidence of drug abuse on urine testing.
- Positive test for hepatitis B, hepatitis C, human immune deficiency virus 1 or human immune deficiency virus 2.
- Severe bleedings from fibroids.
- Anemia (hemoglobin less than 11 g/dL), loss of more than 400 mL blood during the 3 months before the study.
- Use of oral contraceptives or other estrogen containing medication, progestins, danazol, progesterone antagonists, antiandrogens, steroids or gonadotropins which might affect sex steroid production or activity or assay (e.g. norethindrone) within 30 days prior to study enrolment.
About this study
Official title: 3 Months, Open-Label, Parallel-Group Study of the Pharmacodynamics, Pharmacokinetics and Safety of TAP-144SR 1-month Depot Gelatin-Free vs. Gelatin-Containing Formulation in Female Patients With Uterine Fibroids
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.
Read the detailed description
Gonadotropin-releasing hormone, also called luteinizing hormone releasing hormone, is a neuropeptide hormone released from the hypothalamus. Gonadotropin-releasing hormone binds to specific gonadotropin-releasing hormone receptors in the cell membrane of pituitary gland cells, inducing the cells to produce and release the gonadotropins: luteinizing hormone and follicle-stimulating hormone. Luteinizing hormone and follicle-stimulating hormone are released into the general circulation and stimulate the gonads to produce and release the sex steroids: testosterone and estrogen. Follicle-stimulating hormone also controls gametogenesis.
Suppression of gonadotropin secretion is an effective treatment for conditions such as prostate cancer, endometriosis and central precocious puberty, because these conditions respond to manipulation of the sex steroids. Suppression of gonadotropin secretion can be achieved by administration of gonadotropin-releasing hormone agonists that, after an initial transient stimulation of gonadotropin release, reversibly desensitize pituitary gonadotropin-releasing hormone receptors. Desensitization is thought to occur by down-regulation of the numbers of gonadotropin-releasing hormone receptors and uncoupling of the receptors from the biochemical pathway that leads to gonadotropin release. Termination of gonadotropin-releasing hormone agonist administration reverses the desensitization, and gonadotropin and sex hormone levels return to normal.
There are several marketed gonadotropin-releasing hormone agonists, one of which is TAP-144 (leuprorelin), an active synthetic nonapeptide gonadotropin-releasing hormone analogue. In the present study, the existing leuprorelin 1- month sustained release formulation will be compared with a new gelatin-free 1-month sustained release formulation.
- Conditions
- Uterine Fibroids
- Being tested
- Leuprorelin (GF), Leuprorelin (GC)
- Keywords
- Leiomyoma, Uterine Fibroids, Drug Therapy, Uterine Neoplasms, Fibroid Tumor
- Medical subject headings
- Leiomyoma, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprorelin (GF)Drug
Also called Leuplin, Enantone, Trenantone, TAP-144SR
Leuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
Leuprorelin (GC)Drug
Also called Leuplin, Enantone, Trenantone, TAP-144SR
Leuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Leuprorelin (GF) | Experimental | Not described Receives: Drug: Leuprorelin (GF) |
| Leuprorelin (GC) | Experimental | Not described Receives: Drug: Leuprorelin (GC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL.
Measured: Weeks 5 through Final Visit.
Secondary outcomes (3)
Time course of E2 (17β-estradiol) Serum Concentration levels.
Measured: At all Visits.
Time course of E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL.
Measured: Week 5 through Final Visit.
Rate of E2 (17β-estradiol) Serum Concentration levels less than or equal to 50, 40 and 30 ng/dL.
Measured: At all Visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Takeda Pharma Gmbh, Aachen (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776074
- Sponsor's protocol ID
- ENG K001 GF
- Other IDs
- 2005-005641-19, EC 406, U1111-1114-2217, 2005
- Status last verified
- Jun 2010
- First submitted
- 16 Oct 2008
- Last updated
- 22 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 Months, Open-Label, Parallel-Group Study of the Pharmacodynamics, Pharmacokinetics and Safety of TAP-144SR 1-month Depot Gelatin-Free vs. Gelatin-Containing Formulation in Female Patients With Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00776074
- Acronym / sponsor ID
- ENG K001 GF
- Conditions
- Uterine Fibroids
- Keywords
- Leiomyoma, Uterine Fibroids, Drug Therapy, Uterine Neoplasms, Fibroid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 20 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the pharmacodynamics of leuprorelin gelatin free formulation (GF) to leuprorelin gelatin containing formulation (GC) in female subjects with uterine fibroids.
Detailed description
Gonadotropin-releasing hormone, also called luteinizing hormone releasing hormone, is a neuropeptide hormone released from the hypothalamus. Gonadotropin-releasing hormone binds to specific gonadotropin-releasing hormone receptors in the cell membrane of pituitary gland cells, inducing the cells to produce and release the gonadotropins: luteinizing hormone and follicle-stimulating hormone. Luteinizing hormone and follicle-stimulating hormone are released into the general circulation and stimulate the gonads to produce and release the sex steroids: testosterone and estrogen. Follicle-stimulating hormone also controls gametogenesis.
Suppression of gonadotropin secretion is an effective treatment for conditions such as prostate cancer, endometriosis and central precocious puberty, because these conditions respond to manipulation of the sex steroids. Suppression of gonadotropin secretion can be achieved by administration of gonadotropin-releasing hormone agonists that, after an initial transient stimulation of gonadotropin release, reversibly desensitize pituitary gonadotropin-releasing hormone receptors. Desensitization is thought to occur by down-regulation of the numbers of gonadotropin-releasing hormone receptors and uncoupling of the receptors from the biochemical pathway that leads to gonadotropin release. Termination of gonadotropin-releasing hormone agonist administration reverses the desensitization, and gonadotropin and sex hormone levels return to normal.
There are several marketed gonadotropin-releasing hormone agonists, one of which is TAP-144 (leuprorelin), an active synthetic nonapeptide gonadotropin-releasing hormone analogue. In the present study, the existing leuprorelin 1- month sustained release formulation will be compared with a new gelatin-free 1-month sustained release formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leuprorelin (GF) | Experimental | Drug: Leuprorelin (GF) |
| Leuprorelin (GC) | Experimental | Drug: Leuprorelin (GC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients with measurable uterine fibroids confirmed by vaginal or abdominal ultrasound, deemed otherwise healthy.
- A body mass index in the range 18 to 28.
- Oestradiol, progesterone, luteinizing hormone and follicle stimulating hormone results within the range of normal ovarian function.
- Regular menstruation (except for symptoms of fibroids).
- Females of childbearing potential who are sexually active must agree to use barrier contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Key exclusion criteria (13 listed)
- Acute pelvioperitonitis, ovarian cysts, persistent corpus luteum.
- History of bilateral oophorectomy, hysterectomy, or hypophysectomy.
- Clinically relevant abnormal history, physical findings, or laboratory values at the pre-study screening assessment that could interfere with the objectives of the study or the safety of the patient.
- Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the patient participation in the study or make it unnecessarily hazardous.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
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 |
|---|---|---|
| Leuprorelin (GF)Also: Leuplin, Enantone, Trenantone, TAP-144SRLeuprorelin (GF) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks. | Drug | Leuprorelin (GF) |
| Leuprorelin (GC)Also: Leuplin, Enantone, Trenantone, TAP-144SRLeuprorelin (GC) 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks. | Drug | Leuprorelin (GC) |
Primary outcome
Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL.
Time frame: Weeks 5 through Final Visit.
3 secondary outcomes
Time course of E2 (17β-estradiol) Serum Concentration levels.
Time frame: At all Visits.
Time course of E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL.
Time frame: Week 5 through Final Visit.
Rate of E2 (17β-estradiol) Serum Concentration levels less than or equal to 50, 40 and 30 ng/dL.
Time frame: At all Visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2010.
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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.
Medical Director study director
Takeda Pharma Gmbh, Aachen (Germany)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Leuprorelin (GF) and Leuprorelin (GC) in people with Uterine Fibroids, run by Takeda.
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 5 inclusion and 13 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 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of measured E2 (17β-estradiol) Serum Concentrations less than or equal to 30 pg/mL. (time frame: Weeks 5 through Final Visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2010.