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NCT02943655 Clinical Trial

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

Heavy Menstrual Bleeding Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02943655
Other study ID # HVB
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 1, 2017
Est. completion date February 10, 2021

Study information
Verified date June 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date February 10, 2021
Est. primary completion date October 10, 2020
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• combined contraceptive pills (microcept)
oral combined contraceptive once daily
• medroxyprogesterone acetate (progest)
oral 5 mg medroxyprogesterone acetate daily
• mefenamic acid (ponstan forte)
oral 500 mg mefenamic acid three times per day

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the amount of menstrual blood loss 3 months
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