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Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)

Information source: Assiut University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Uterine Hemorrhage

Intervention: Doxycycline (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Omar Mamdouh Shaaban

Official(s) and/or principal investigator(s):
Hany Abdel-Aleem, MD, Principal Investigator, Affiliation: Assiut University
Omar M Shaaban, MD, Study Director, Affiliation: Assiut University
Mahmoud Abdel=Aleem, MD, Study Chair, Affiliation: Assiut University
Gehian N Fetih, PH.D, Study Chair, Affiliation: Faculty of Pharmacy, Assiut University

Summary

This study aims to test the effect of Doxycycline in treatment of uterine bleeding during the use of injectable contraception that contains one hormone "progesterone only".

Clinical Details

Official title: Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Stoppage of bleeding within 7 days

Secondary outcome:

Number of days needed to stop a current attack of bleeding

Next bleeding free interval

Uterine bleeding patterns in the next 3 months after treatment

Women satisfaction with the treatment she received

Side effects encountered during treatment

Discontinuation of the DMPA and its reason

Eligibility

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Women under DMPA contraception for at least one month. 2. Accept to participate in the trial after receiving adequate information about the trial including information that she is a part of randomization comprising the possibility of receiving new treatment for bleeding or inactive ingredients. 3. Women's ability to keep an accurate menstrual diary for the study. Exclusion Criteria: 1. Lactating women for the fear of the effect of tetracycline on the breast-fed infant. 2. Patients with already diagnosed local gynecological abnormality. 3. Women receiving treatment for bleeding within the last one month.

Locations and Contacts

Faculty of Medicine, Assiut, Egypt
Additional Information

Starting date: January 2008
Last updated: November 25, 2011

Page last updated: August 23, 2015

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