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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01254799
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : November 28, 2011
Information provided by (Responsible Party):
Omar Mamdouh Shaaban, Assiut University

Brief 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".

Condition or disease Intervention/treatment Phase
Uterine Hemorrhage Drug: Doxycycline Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
Study Start Date : January 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Stoppage of bleeding within 7 days [ Time Frame: 7 days from starting of tretment ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01254799

Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
Omar Mamdouh Shaaban
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Omar Mamdouh Shaaban, Dr, Assiut University Identifier: NCT01254799     History of Changes
Other Study ID Numbers: DOX-DMPA
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Medroxyprogesterone Acetate
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents