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Clinical Trials/NCT02943655
NCT02943655CompletedPhase 3

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

Assiut University1 site in 1 country240 target enrollmentStarted: November 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
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

Active Comparator

oral second generation pills one tablet daily

Intervention: combined contraceptive pills (microcept) (Drug)

medroxyprogesterone acetate

Active Comparator

oral 5 mg daily

Intervention: medroxyprogesterone acetate (progest) (Drug)

non-steroidal anti-inflammatory

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Abbas

Dr

Assiut University

Study Sites (1)

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