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

NCT ID: NCT02103764

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2018-12-31

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:

1. Endometrial histopathology changes

2. 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.

Conditions

Dysfunctional Uterine Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Desogestrel

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

Group Type: EXPERIMENTAL

Desogestrel

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Medroxyprogesterone acetate

Intervention Type: DRUG

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

Interventions

Desogestrel

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Cerazette; Provera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Manee Rattanachaiyanont

Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manee Rattanachaiyanont, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 35102226 (View on PubMed)

Other Identifiers

DSG-SIAUB

Identifier Type: -

Identifier Source: org_study_id