Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-02-10

Brief Summary

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Abnormal uterine bleeding encompasses abnormalities in the regularity, duration of flow, frequency, and/or blood flow volume relative to normal menstruation. Of these menstrual abnormalities, heavy menstrual bleeding (HMB), defined objectively as a blood loss of 80 ml or more per menstrual cycle , which is unrelated to pregnancy or known pelvic or systemic disease.

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Detailed Description

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Conditions

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Improve Quality of Life Heavy Menstrual Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combined oral contraceptives

oral second generation pills one tablet daily

Group Type ACTIVE_COMPARATOR

combined contraceptive pills (microcept)

Intervention Type DRUG

oral combined contraceptive once daily

medroxyprogesterone acetate

oral 5 mg daily

Group Type ACTIVE_COMPARATOR

medroxyprogesterone acetate (progest)

Intervention Type DRUG

oral 5 mg medroxyprogesterone acetate daily

non-steroidal anti-inflammatory

oral 500 mg mefenamic acid three times per day

Group Type ACTIVE_COMPARATOR

mefenamic acid (ponstan forte)

Intervention Type DRUG

oral 500 mg mefenamic acid three times per day

Interventions

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combined contraceptive pills (microcept)

oral combined contraceptive once daily

Intervention Type DRUG

medroxyprogesterone acetate (progest)

oral 5 mg medroxyprogesterone acetate daily

Intervention Type DRUG

mefenamic acid (ponstan forte)

oral 500 mg mefenamic acid three times per day

Intervention Type DRUG

Other Intervention Names

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microcept progest ponstan forte

Eligibility Criteria

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Inclusion Criteria

Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding involving at least last three consecutive menstrual cycles.

Exclusion Criteria

1. Postmenopausal bleeding (over one year since the last menstrual period).
2. Irregular menses or intermenstrual bleeding.
3. Organic causes of heavy menstrual bleeding suspected or confirmed by experienced abdominal and transvaginal ultrasound after thorough general and gynecological examination.
4. Iatrogenic (treatment-related) causes of heavy menstrual bleeding (e.g. non-progestogen-releasing intrauterine contraceptive device, oral contraceptives, other hormonal drug use or anticoagulant agent).
5. Iron deficiency anemia.
6. History of chronic diseases known to interfere with menstrual bleeding or prevent the use of any of the listed drugs e.g previous or current thromboembolic disease.

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No