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

Dysfunctional Uterine Bleeding Clinical Trial

— SI-AUB-RCT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02103764
• Other study ID #: DSG-SIAUB
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysfunctional Uterine Bleeding
• Hemorrhage
• Metrorrhagia
• Uterine Hemorrhage

Intervention

Drug:
• Desogestrel
Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
• Medroxyprogesterone acetate
Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The occurrence of withdrawal bleeding	To compare the occurrence of withdrawal bleeding between cyclic DSG and cyclic MPA groups.	6 months
Secondary	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
Secondary	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
Secondary	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