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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02943655

Enrollment

240

Registered

2016-10-25

Start date

2017-11-01

Completion date

2021-02-10

Last updated

2021-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Menstrual Bleeding, Improve Quality of Life

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.

Interventions

DRUGcombined contraceptive pills (microcept)

oral combined contraceptive once daily

DRUGmedroxyprogesterone acetate (progest)

oral 5 mg medroxyprogesterone acetate daily

DRUGmefenamic acid (ponstan forte)

oral 500 mg mefenamic acid three times per day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
the amount of menstrual blood loss	3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026