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

NCT02943655 | Completed Phase 3 DMC

• 1 other identifier: HVB
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Improve Quality of Life; Heavy Menstrual Bleeding

Outcome Measures

Primary Outcomes (1)

• the amount of menstrual blood loss

  3 months

Study Arms (3)

combined oral contraceptives

ACTIVE COMPARATOR

oral second generation pills one tablet daily

Drug: combined contraceptive pills (microcept)

medroxyprogesterone acetate

ACTIVE COMPARATOR

oral 5 mg daily

Drug: medroxyprogesterone acetate (progest)

non-steroidal anti-inflammatory

ACTIVE COMPARATOR

oral 500 mg mefenamic acid three times per day

Drug: mefenamic acid (ponstan forte)

Interventions

combined contraceptive pills (microcept) DRUG

oral combined contraceptive once daily

Also known as: microcept

combined oral contraceptives

medroxyprogesterone acetate (progest) DRUG

oral 5 mg medroxyprogesterone acetate daily

Also known as: progest

medroxyprogesterone acetate

mefenamic acid (ponstan forte) DRUG

oral 500 mg mefenamic acid three times per day

Also known as: ponstan forte

non-steroidal anti-inflammatory

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Regular menstrual cycles with BMI (19-29 kg/m2). Heavy and/or prolonged menstrual bleeding involving at least last three consecutive menstrual cycles.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Menorrhagia

Interventions

Medroxyprogesterone Acetate; Progest; Mefenamic Acid

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 25, 2016
• Study Start: November 1, 2017
• Primary Completion: October 10, 2020
• Study Completion: February 10, 2021
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

EG (1)