Back to resultsTreatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Primary Purpose
Improve Quality of Life, Heavy Menstrual Bleeding
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
combined contraceptive pills (microcept)
medroxyprogesterone acetate (progest)
mefenamic acid (ponstan forte)
Sponsored by
About this trial
This is an interventional treatment trial for Improve Quality of Life
Eligibility Criteria
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.
Sites / Locations
- Ahmed Abbas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
combined oral contraceptives
medroxyprogesterone acetate
non-steroidal anti-inflammatory
Arm Description
oral second generation pills one tablet daily
oral 5 mg daily
oral 500 mg mefenamic acid three times per day
Outcomes
Primary Outcome Measures
the amount of menstrual blood loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02943655
Brief Title
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Official Title
Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
February 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improve Quality of Life, Heavy Menstrual Bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combined oral contraceptives
Arm Type
Active Comparator
Arm Description
oral second generation pills one tablet daily
Arm Title
medroxyprogesterone acetate
Arm Type
Active Comparator
Arm Description
oral 5 mg daily
Arm Title
non-steroidal anti-inflammatory
Arm Type
Active Comparator
Arm Description
oral 500 mg mefenamic acid three times per day
Intervention Type
Drug
Intervention Name(s)
combined contraceptive pills (microcept)
Other Intervention Name(s)
microcept
Intervention Description
oral combined contraceptive once daily
Intervention Type
Drug
Intervention Name(s)
medroxyprogesterone acetate (progest)
Other Intervention Name(s)
progest
Intervention Description
oral 5 mg medroxyprogesterone acetate daily
Intervention Type
Drug
Intervention Name(s)
mefenamic acid (ponstan forte)
Other Intervention Name(s)
ponstan forte
Intervention Description
oral 500 mg mefenamic acid three times per day
Primary Outcome Measure Information:
Title
the amount of menstrual blood loss
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
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