AdenomyosisNCT03890042
Dienogest for Treatment of Adenomyotic Uteri
A study testing Dienogest group, Gestodene-Ethinyl Estradiol and Ultrasound in people with Adenomyosis, run by Assiut University at 1 site in Egypt.
Trial summary
Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Adenomyosis
- What is being tested?
- Dienogest group, Gestodene-Ethinyl Estradiol and Ultrasound
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Aug 2020
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20-40 years
- Women with ultrasonographic evidence of adenomyosis
- Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
Who cannot join
- Women with a history of malignancy or histological evidence of endometrial hyperplasia
- any adnexal abnormality on ultrasound
- undiagnosed vaginal
- contraindication to receive Vissane or gynera .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.
Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis
- Conditions
- Adenomyosis
- Being tested
- Dienogest group, Gestodene-Ethinyl Estradiol, Ultrasound, visual analogue scale
- Medical subject headings
- Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dienogest groupDrug
VISANNE 2MG Tablet once daily
Gestodene-Ethinyl EstradiolDrug
Gynera tablet once daily
UltrasoundRadiation
ultrasound assessment of uterine volume
visual analogue scaleOther
visual analogue scale for assessment of pain
| Study group | Role | What they receive |
|---|---|---|
| Dienogest group | Active comparator | Not described Receives: Drug: Dienogest group; Radiation: Ultrasound; Other: visual analogue scale |
| Gynera group | Active comparator | Not described Receives: Drug: Gestodene-Ethinyl Estradiol; Radiation: Ultrasound; Other: visual analogue scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women who will improved from the pelvic pain measured by visual analogue scale
Measured: 6 months
Secondary outcomes (1)
Uterine volume (cm 3 ) measure by ultrasound
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Mar 2019
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890042
- Sponsor's protocol ID
- DAD
- Status last verified
- Aug 2020
- First submitted
- 23 Mar 2019
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassanin AI, Youssef AA, Yousef AM, Ali MK. Comparison of dienogest versus combined oral contraceptive pills in the treatment of women with adenomyosis: A randomized clinical trial. Int J Gynaecol Obstet. 2021 Aug;154(2):263-269. doi: 10.1002/ijgo.13600. Epub 2021 Feb 11.
PubMed 33454995
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
- ClinicalTrials.gov ID
- NCT03890042
- Acronym / sponsor ID
- DAD
- Conditions
- Adenomyosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- 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.
Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.
Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dienogest group | Active comparator | Drug: Dienogest group, Radiation: Ultrasound, Other: visual analogue scale |
| Gynera group | Active comparator | Drug: Gestodene-Ethinyl Estradiol, Radiation: Ultrasound, Other: visual analogue scale |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 20-40 years
- Women with ultrasonographic evidence of adenomyosis
- Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
Key exclusion criteria (4 listed)
- Women with a history of malignancy or histological evidence of endometrial hyperplasia
- any adnexal abnormality on ultrasound
- undiagnosed vaginal
- contraindication to receive Vissane or gynera .
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 |
|---|---|---|
| Dienogest groupVISANNE 2MG Tablet once daily | Drug | Dienogest group |
| Gestodene-Ethinyl EstradiolGynera tablet once daily | Drug | Gynera group |
| Ultrasoundultrasound assessment of uterine volume | Radiation | Dienogest group, Gynera group |
| visual analogue scalevisual analogue scale for assessment of pain | Other | Dienogest group, Gynera group |
Primary outcome
Number of women who will improved from the pelvic pain measured by visual analogue scale
Time frame: 6 months
1 secondary outcome
Uterine volume (cm 3 ) measure by ultrasound
Time frame: 6 month
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 25 Aug 2020.
- Derived from this study: PubMed 33454995Hassanin AI, Youssef AA, Yousef AM, Ali MK. Comparison of dienogest versus combined oral contraceptive pills in the treatment of women with adenomyosis: A randomized clinical trial. Int J Gynaecol Obstet. 2021 Aug;154(2):263-269. doi: 10.1002/ijgo.13600. Epub 2021 Feb 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dienogest group, Gestodene-Ethinyl Estradiol and Ultrasound in people with Adenomyosis, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 4 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 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Number of women who will improved from the pelvic pain measured by visual analogue scale (time frame: 6 months). 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 NCT03890042, 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 25 Aug 2020.