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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02943655

Collaborator

(none)

240

Enrollment

Location

Arms

39.3

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Improve Quality of Life Heavy Menstrual Bleeding	Drug: combined contraceptive pills (microcept) Drug: medroxyprogesterone acetate (progest) Drug: mefenamic acid (ponstan forte)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Oct 10, 2020

Actual Study Completion Date :

Feb 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: combined oral contraceptives oral second generation pills one tablet daily	Drug: combined contraceptive pills (microcept) oral combined contraceptive once daily Other Names: microcept
Active Comparator: medroxyprogesterone acetate oral 5 mg daily	Drug: medroxyprogesterone acetate (progest) oral 5 mg medroxyprogesterone acetate daily Other Names: progest
Active Comparator: non-steroidal anti-inflammatory oral 500 mg mefenamic acid three times per day	Drug: mefenamic acid (ponstan forte) oral 500 mg mefenamic acid three times per day Other Names: ponstan forte

Arm

Intervention/Treatment

Active Comparator: combined oral contraceptives

oral second generation pills one tablet daily

Drug: combined contraceptive pills (microcept)

oral combined contraceptive once daily

Other Names:

microcept

Active Comparator: medroxyprogesterone acetate

oral 5 mg daily

Drug: medroxyprogesterone acetate (progest)

oral 5 mg medroxyprogesterone acetate daily

Other Names:

progest

Active Comparator: non-steroidal anti-inflammatory

oral 500 mg mefenamic acid three times per day

Drug: mefenamic acid (ponstan forte)

oral 500 mg mefenamic acid three times per day

Other Names:

ponstan forte

Outcome Measures

Primary Outcome Measures

the amount of menstrual blood loss [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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:

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.