- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02943655
Treatment of Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause
June 1, 2021 updated by: Ahmed Mohamed Abbas, Assiut University
Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Cairo
-
Assiut, Cairo, Egypt, 002
- Ahmed Abbas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: combined oral contraceptives
oral second generation pills one tablet daily
|
oral combined contraceptive once daily
Other Names:
|
ACTIVE_COMPARATOR: medroxyprogesterone acetate
oral 5 mg daily
|
oral 5 mg medroxyprogesterone acetate daily
Other Names:
|
ACTIVE_COMPARATOR: non-steroidal anti-inflammatory
oral 500 mg mefenamic acid three times per day
|
oral 500 mg mefenamic acid three times per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the amount of menstrual blood loss
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 1, 2017
Primary Completion (ACTUAL)
October 10, 2020
Study Completion (ACTUAL)
February 10, 2021
Study Registration Dates
First Submitted
October 21, 2016
First Submitted That Met QC Criteria
October 24, 2016
First Posted (ESTIMATE)
October 25, 2016
Study Record Updates
Last Update Posted (ACTUAL)
June 4, 2021
Last Update Submitted That Met QC Criteria
June 1, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Uterine Diseases
- Menstruation Disturbances
- Uterine Hemorrhage
- Hemorrhage
- Menorrhagia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Progestins
- Contraceptive Agents, Male
- Contraceptive Agents
- Progesterone
- Mefenamic Acid
- Medroxyprogesterone Acetate
- Medroxyprogesterone
Other Study ID Numbers
- HVB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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