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

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.

Official Title
-----------------
Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause

Conditions
-----------------
Improve Quality of Life, Heavy Menstrual Bleeding

Intervention / Treatment
-----------------
* Drug: combined contraceptive pills (microcept)
* Drug: medroxyprogesterone acetate (progest)
* Drug: mefenamic acid (ponstan forte)


Participation Criteria
=================
Eligibility 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: combined oral contraceptives<br>oral second generation pills one tablet daily | Drug: combined contraceptive pills (microcept)<br>* oral combined contraceptive once daily<br>* Other names: microcept;|
| Active Comparator: medroxyprogesterone acetate<br>oral 5 mg daily | Drug: medroxyprogesterone acetate (progest)<br>* oral 5 mg medroxyprogesterone acetate daily<br>* Other names: progest;|
| Active Comparator: non-steroidal anti-inflammatory<br>oral 500 mg mefenamic acid three times per day | Drug: mefenamic acid (ponstan forte)<br>* oral 500 mg mefenamic acid three times per day<br>* Other names: ponstan forte;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of menstrual blood loss |  | 3 months |