SI-AUB-RCT: Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB

Sponsor

Mahidol University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02103764

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

Endometrial histopathology changes
Menstrual cycle control.

Condition or Disease	Intervention/Treatment	Phase
Dysfunctional Uterine Bleeding	Drug: Desogestrel Drug: Medroxyprogesterone acetate	Phase 3

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

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desogestrel Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month	Drug: Desogestrel Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month Other Names: Cerazette
Active Comparator: Medroxyprogesterone acetate 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 Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month Other Names: Provera

Arm

Intervention/Treatment

Experimental: Desogestrel

Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month

Drug: Desogestrel

Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month

Other Names:

Cerazette

Active Comparator: Medroxyprogesterone acetate

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

Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month

Other Names:

Provera

Outcome Measures

Primary Outcome Measures

The change in endometrial histology [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.

Secondary Outcome Measures

The occurrence of withdrawal bleeding [6 months]
To compare the occurrence of withdrawal bleeding between cyclic DSG and cyclic MPA groups.
Effect of cyclic DSG on lipid metabolism compared with cyclic MPA [6 months]
To compare the change of total cholesterol (TC), triglyceride, HDL-C, and LDL-C between cyclic DSG and cyclic MPA groups.
Effect of cyclic DSG on glucose metabolism compared with cyclic MPA [6 months]
To compare the change of fasting blood glucose, and fasting insulin between cyclic DSG and cyclic MPA groups.
Adverse events [At day 8 or 9 or 10 of the first cycle and 3, 6 month]
To compare the adverse events, including side effects between cyclic DSG and cyclic MPA groups.