Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Assiut University
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- the amount of menstrual blood loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •Postmenopausal bleeding (over one year since the last menstrual period).
- •Irregular menses or intermenstrual bleeding.
- •Organic causes of heavy menstrual bleeding suspected or confirmed by experienced abdominal and transvaginal ultrasound after thorough general and gynecological examination.
- •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).
- •Iron deficiency anemia.
- •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.
Arms & Interventions
combined oral contraceptives
oral second generation pills one tablet daily
Intervention: combined contraceptive pills (microcept) (Drug)
medroxyprogesterone acetate
oral 5 mg daily
Intervention: medroxyprogesterone acetate (progest) (Drug)
non-steroidal anti-inflammatory
oral 500 mg mefenamic acid three times per day
Intervention: mefenamic acid (ponstan forte) (Drug)
Outcomes
Primary Outcomes
the amount of menstrual blood loss
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Mohamed Abbas
Dr
Assiut University