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

Phase 3

Completed

• Conditions: Heavy Menstrual Bleeding; Improve Quality of Life
• Interventions: Drug: medroxyprogesterone acetate (progest); Drug: mefenamic acid (ponstan forte); Drug: combined contraceptive pills (microcept)

• Registration Number: NCT02943655
• Lead Sponsor: Assiut University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-25
• Study Start: 2017-11-01
• Primary Completion: 2020-10-10
• Study Completion: 2021-02-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-01
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medroxyprogesterone acetate	medroxyprogesterone acetate (progest)	oral 5 mg daily
non-steroidal anti-inflammatory	mefenamic acid (ponstan forte)	oral 500 mg mefenamic acid three times per day
combined oral contraceptives	combined contraceptive pills (microcept)	oral second generation pills one tablet daily

Primary Outcome Measures

Name	Time	Method
the amount of menstrual blood loss	3 months

Trial Locations

Locations (1)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt