Dysfunctional Uterine BleedingPhase 3SI-AUB-RCTNCT02103764
Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB
A Phase 3 study testing Desogestrel and Medroxyprogesterone acetate in people with Dysfunctional Uterine Bleeding, run by Mahidol University at 1 site in Thailand.
Trial summary
The objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects: 1. Endometrial histopathology changes 2. Menstrual cycle control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- Desogestrel and Medroxyprogesterone acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2013to Dec 2018
- Phase
- Phase 3
- 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
- Premenopausal women with anovular DUB (proved by endometrial histology)
- Age > 18 yr.
Who cannot join
- Any uterine pathology that might cause abnormal uterine bleeding
- Contraindication to progestin treatment (such as breast cancer)
- Severe drug allergy towards a progestogen
- Intake of any hormonal treatment in the previous 3 months
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial
The objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects:
- Endometrial histopathology changes
- Menstrual cycle control.
Read the detailed description
Anovulatory dysfunctional uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding especially in postmenarcheal adolescent, perimenopausal women, patient with polycystic ovary syndrome (PCOS) and in obese women. Aims of treatment in women with anovulatory DUB are to restore the natural control mechanism of endometrium (introduce normal synchronous growth, development, shedding of a structural stable endometrium) and to prevent endometrial hyperplasia. The two main treatment options are estrogen-progestin therapy and progestin therapy. Women who are sexually active and not immediately prepared to pursue pregnancy are best manage by estrogen-progestin treatment especially combined oral contraceptive pills (COCs) but in perimenopausal women, obese women or women who can't tolerate COCs or have contraindications in using COCs, cyclic progestin will be the treatment of choice. Common used progestin in anovulatory DUB is medroxyprogesterone acetate (MPA) 5-10 mg/day for 10-14 days each month. This progestin has strong progestogenic effect but has some undesirable effect such as glucocorticoid effect, mineralocorticoid effect and androgenic effect. Long term using this progestin especially in obese women or perimenopausal women who have risk for diabetes mellitus and dyslipidemia may be negative effect to glucose and lipid metabolism. DSG is the third generation progestin with no glucocorticoid, mineralocorticoid effect and low androgenic effect may be the better choice of treatment but the data of DSG in treatment of anovulatory DUB us scanty. So this study will evaluate the effect of cyclic DSG in endometrial histology changing and lipid, glucose metabolism in patient with anovulatory DUB.
Comparison : Women with anovulatory DUB are randomized into two groups, receiving a course of either cyclic DSG or cyclic MPA. The main outcome measured is to compare the effect of both interventions on endometrial histology changing.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- Desogestrel, Medroxyprogesterone acetate
- Keywords
- Anovulatory Dysfunctional Uterine Bleeding, cyclic desogestrel, cyclic medroxyprogesterone acetate, lipid metabolism, glucose metabolism, endometrial histology changing
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesogestrelDrug
Also called Cerazette
Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
Medroxyprogesterone acetateDrug
Also called Provera
Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month
| Study group | Role | What they receive |
|---|---|---|
| Desogestrel | Experimental | Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month Receives: Drug: Desogestrel |
| Medroxyprogesterone acetate | Active comparator | Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month Receives: Drug: Medroxyprogesterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in endometrial histology
The participants are evaluated for changing of endometrial histology at day 8 or 9 or 10 of treatment period.
Measured: Baseline, Day 8 or 9 or 10 of treatment period in first month
Secondary outcomes (4)
The occurrence of withdrawal bleeding
To compare the occurrence of withdrawal bleeding between cyclic DSG and cyclic MPA groups.
Measured: 6 months
Effect of cyclic DSG on lipid metabolism compared with cyclic MPA
To compare the change of total cholesterol (TC), triglyceride, HDL-C, and LDL-C between cyclic DSG and cyclic MPA groups.
Measured: 6 months
Effect of cyclic DSG on glucose metabolism compared with cyclic MPA
To compare the change of fasting blood glucose, and fasting insulin between cyclic DSG and cyclic MPA groups.
Measured: 6 months
Adverse events
To compare the adverse events, including side effects between cyclic DSG and cyclic MPA groups.
Measured: At day 8 or 9 or 10 of the first cycle and 3, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startAug 2013
- Primary completionJul 2018
- Study completionDec 2018 (estimated)
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 Dysfunctional Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Mahidol 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manee Rattanachaiyanont, Mahidol University
- Investigators
- Manee Rattanachaiyanont, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103764
- Sponsor's protocol ID
- DSG-SIAUB
- Acronym
- SI-AUB-RCT
- Status last verified
- Aug 2018
- First submitted
- 18 Feb 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Soontrapa N, Rattanachaiyanont M, Warnnissorn M, Wongwananuruk T, Indhavivadhana S, Tanmahasamut P, Techatraisak K, Angsuwathana S. The effectiveness of desogestrel for endometrial protection in women with abnormal uterine bleeding-ovulatory dysfunction: a non-inferiority randomized controlled trial. Sci Rep. 2022 Jan 31;12(1):1662. doi: 10.1038/s41598-022-05578-0.
PubMed 35102226
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02103764
- Acronym / sponsor ID
- SI-AUB-RCT / DSG-SIAUB
- Conditions
- Dysfunctional Uterine Bleeding
- Keywords
- Anovulatory Dysfunctional Uterine Bleeding, cyclic desogestrel, cyclic medroxyprogesterone acetate, lipid metabolism, glucose metabolism, endometrial histology changing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 4 Apr 2014 (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 objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects:
- Endometrial histopathology changes
- Menstrual cycle control.
Detailed description
Anovulatory dysfunctional uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding especially in postmenarcheal adolescent, perimenopausal women, patient with polycystic ovary syndrome (PCOS) and in obese women. Aims of treatment in women with anovulatory DUB are to restore the natural control mechanism of endometrium (introduce normal synchronous growth, development, shedding of a structural stable endometrium) and to prevent endometrial hyperplasia. The two main treatment options are estrogen-progestin therapy and progestin therapy. Women who are sexually active and not immediately prepared to pursue pregnancy are best manage by estrogen-progestin treatment especially combined oral contraceptive pills (COCs) but in perimenopausal women, obese women or women who can't tolerate COCs or have contraindications in using COCs, cyclic progestin will be the treatment of choice. Common used progestin in anovulatory DUB is medroxyprogesterone acetate (MPA) 5-10 mg/day for 10-14 days each month. This progestin has strong progestogenic effect but has some undesirable effect such as glucocorticoid effect, mineralocorticoid effect and androgenic effect. Long term using this progestin especially in obese women or perimenopausal women who have risk for diabetes mellitus and dyslipidemia may be negative effect to glucose and lipid metabolism. DSG is the third generation progestin with no glucocorticoid, mineralocorticoid effect and low androgenic effect may be the better choice of treatment but the data of DSG in treatment of anovulatory DUB us scanty. So this study will evaluate the effect of cyclic DSG in endometrial histology changing and lipid, glucose metabolism in patient with anovulatory DUB.
Comparison : Women with anovulatory DUB are randomized into two groups, receiving a course of either cyclic DSG or cyclic MPA. The main outcome measured is to compare the effect of both interventions on endometrial histology changing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desogestrel | Experimental | Drug: DesogestrelDesogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month |
| Medroxyprogesterone acetate | Active comparator | Drug: Medroxyprogesterone acetateMedroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Premenopausal women with anovular DUB (proved by endometrial histology)
- Age > 18 yr.
Key exclusion criteria (4 listed)
- Any uterine pathology that might cause abnormal uterine bleeding
- Contraindication to progestin treatment (such as breast cancer)
- Severe drug allergy towards a progestogen
- Intake of any hormonal treatment in the previous 3 months
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 |
|---|---|---|
| DesogestrelAlso: CerazetteDesogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month | Drug | Desogestrel |
| Medroxyprogesterone acetateAlso: ProveraMedroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month | Drug | Medroxyprogesterone acetate |
Primary outcome
The change in endometrial histology
Time frame: Baseline, Day 8 or 9 or 10 of treatment period in first month
The participants are evaluated for changing of endometrial histology at day 8 or 9 or 10 of treatment period.
4 secondary outcomes
The occurrence of withdrawal bleeding
Time frame: 6 months
Effect of cyclic DSG on lipid metabolism compared with cyclic MPA
Time frame: 6 months
Effect of cyclic DSG on glucose metabolism compared with cyclic MPA
Time frame: 6 months
Adverse events
Time frame: At day 8 or 9 or 10 of the first cycle and 3, 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Derived from this study: PubMed 35102226Soontrapa N, Rattanachaiyanont M, Warnnissorn M, Wongwananuruk T, Indhavivadhana S, Tanmahasamut P, Techatraisak K, Angsuwathana S. The effectiveness of desogestrel for endometrial protection in women with abnormal uterine bleeding-ovulatory dysfunction: a non-inferiority randomized controlled trial. Sci Rep. 2022 Jan 31;12(1):1662. doi: 10.1038/s41598-022-05578-0.
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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.
Manee Rattanachaiyanont, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desogestrel and Medroxyprogesterone acetate in people with Dysfunctional Uterine Bleeding, run by Mahidol University at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Aug 2018. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The change in endometrial histology (time frame: Baseline, Day 8 or 9 or 10 of treatment period in first month). 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 NCT02103764, 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 22 Aug 2018.