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

Assiut University

Status and phase: Completed; Phase 3

Conditions: Improve Quality of Life; Heavy Menstrual Bleeding

Treatments: Drug: medroxyprogesterone acetate (progest); Drug: combined contraceptive pills (microcept); Drug: mefenamic acid (ponstan forte)

Study type: Interventional

Funder types: Other

Identifiers

NCT02943655

HVB

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

combined oral contraceptives

Active Comparator group

Description:

oral second generation pills one tablet daily

Treatment:

Drug: combined contraceptive pills (microcept)

medroxyprogesterone acetate

Active Comparator group

Description:

oral 5 mg daily

Treatment:

Drug: medroxyprogesterone acetate (progest)

non-steroidal anti-inflammatory

Active Comparator group

Description:

oral 500 mg mefenamic acid three times per day

Treatment:

Drug: mefenamic acid (ponstan forte)