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

• Status: Completed
• Trial end date: 2021-02-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Medroxyprogesterone; Medroxyprogesterone Acetate; Mefenamic Acid; Progesterone

Criteria

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.