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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Omar Mamdouh Shaaban, Assiut University
ClinicalTrials.gov Identifier:
NCT01254799
First received: December 6, 2010
Last updated: November 25, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Uterine Hemorrhage
 Drug: Doxycycline
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Vaginal Bleeding
U.S. FDA Resources

Further study details as provided by Assiut University:

Primary Outcome Measures:
  • Stoppage of bleeding within 7 days [ Time Frame: 7 days from starting of tretment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of days needed to stop a current attack of bleeding [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Next bleeding free interval [ Time Frame: 3 month ] [ Designated as safety issue: No ]
  • Uterine bleeding patterns in the next 3 months after treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Women satisfaction with the treatment she received [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Side effects encountered during treatment [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • Discontinuation of the DMPA and its reason [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254799

Locations
Egypt
Faculty of Medicine
Assiut, Egypt
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Omar Mamdouh Shaaban, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT01254799     History of Changes
Other Study ID Numbers: DOX-DMPA
Study First Received: December 6, 2010
Last Updated: November 25, 2011
Health Authority: Egypt: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Doxycycline
Doxycycline hyclate
Medroxyprogesterone
Medroxyprogesterone Acetate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Antimalarials
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

ClinicalTrials.gov processed this record on May 23, 2013