Clinical trial NCT02103764: Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB
Official title: The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dysfunctional Uterine Bleeding
Keywords: Anovulatory Dysfunctional Uterine Bleeding
cyclic desogestrel
cyclic medroxyprogesterone acetate
lipid metabolism
glucose metabolism
endometrial histology changing
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in endometrial histology
timeFrame: Baseline, Day 8 or 9 or 10 of treatment period in first month
Secondary outcomes:
measure: The occurrence of withdrawal bleeding
timeFrame: 6 months
measure: Effect of cyclic DSG on lipid metabolism compared with cyclic MPA
timeFrame: 6 months
measure: Effect of cyclic DSG on glucose metabolism compared with cyclic MPA
timeFrame: 6 months
measure: Adverse events
timeFrame: At day 8 or 9 or 10 of the first cycle and 3, 6 month
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Manee Rattanachaiyanont, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.