Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial

Conditions
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Dysfunctional Uterine Bleeding

Intervention / Treatment
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* Drug: Desogestrel
* Drug: Medroxyprogesterone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal women with anovular DUB (proved by endometrial histology) Age > 18 yr. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desogestrel<br>Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month | Drug: Desogestrel<br>* Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month<br>* Other names: Cerazette;|
| Active Comparator: Medroxyprogesterone acetate<br>Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month | Drug: Medroxyprogesterone acetate<br>* Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month<br>* Other names: Provera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in endometrial histology | The participants are evaluated for changing of endometrial histology at day 8 or 9 or 10 of treatment period. | Baseline, Day 8 or 9 or 10 of treatment period in first month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of withdrawal bleeding | To compare the occurrence of withdrawal bleeding between cyclic DSG and cyclic MPA groups. | 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. | 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. | 6 months | 
| Adverse events | To compare the adverse events, including side effects between cyclic DSG and cyclic MPA groups. | At day 8 or 9 or 10 of the first cycle and 3, 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anovulatory Dysfunctional Uterine Bleeding, cyclic desogestrel, cyclic medroxyprogesterone acetate, lipid metabolism, glucose metabolism, endometrial histology changing