Dysfunctional Uterine Bleeding
Conditions
Keywords
Anovulatory Dysfunctional Uterine Bleeding, cyclic desogestrel, cyclic medroxyprogesterone acetate, lipid metabolism, glucose metabolism, endometrial histology changing
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.
Interventions
DRUGDesogestrel
Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
DRUGMedroxyprogesterone acetate
Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Thailand
Outcome results
None listed