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

November 25, 2011 updated by: Omar Mamdouh Shaaban

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

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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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

  • Egypt
      • Assiut, Egypt
        • Faculty of Medicine

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

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Women in this arm will receive identical Placebo capsules twice daily for 5 days
Drug: Placebo
Placebo capsules twice daily for 5 days
Active Comparator: Doxycycline
Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days
Drug: Doxycycline
100 mg Doxycycline capsules twice daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stoppage of bleeding within 7 days
Time Frame: 7 days from starting of tretment
7 days from starting of tretment

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of days needed to stop a current attack of bleeding
Time Frame: 1 month
1 month
Next bleeding free interval
Time Frame: 3 month
3 month
Uterine bleeding patterns in the next 3 months after treatment
Time Frame: 3 months
3 months
Women satisfaction with the treatment she received
Time Frame: 3 months
3 months
Side effects encountered during treatment
Time Frame: 5 days
5 days
Discontinuation of the DMPA and its reason
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omar Mamdouh Shaaban

Investigators

  • Principal Investigator: Hany Abdel-Aleem, MD, Assiut University
  • Study Director: Omar M Shaaban, MD, Assiut University
  • Study Chair: Mahmoud Abdel=Aleem, MD, Assiut University
  • Study Chair: Gehian N Fetih, PH.D, Faculty of Pharmacy, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 25, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOX-DMPA

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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