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
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Heavy Menstrual Bleeding
• Hemorrhage
• Improve Quality of Life
• Menorrhagia

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