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OpenTrials
Completed

NCT Number: NCT02943655

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

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.

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Key information

Conditions

Improve Quality of Life Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heavy Menstrual Bleeding Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

combined contraceptive pills (microcept)

Drug

oral combined contraceptive once daily

Other names: microcept

medroxyprogesterone acetate (progest)

Drug

oral 5 mg medroxyprogesterone acetate daily

Other names: progest

mefenamic acid (ponstan forte)

Drug

oral 500 mg mefenamic acid three times per day

Other names: ponstan forte

Primary outcomes

  1. the amount of menstrual blood loss

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 25, 2016
Registry last updated
Jun 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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