Text Size

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

December 6, 2010
November 25, 2011
January 2008
September 2010   (final data collection date for primary outcome measure)
Stoppage of bleeding within 7 days [ Time Frame: 7 days from starting of tretment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01254799 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
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".
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Uterine Hemorrhage
  • Drug: Doxycycline
    100 mg Doxycycline capsules twice daily for 5 days
  • Drug: Placebo
    Placebo capsules twice daily for 5 days
  • Placebo Comparator: Placebo
    Women in this arm will receive identical Placebo capsules twice daily for 5 days
    Intervention: Drug: Placebo
  • Active Comparator: Doxycycline
    Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days
    Intervention: Drug: Doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
January 2011
September 2010   (final data collection date for primary outcome measure)

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.
Female
20 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01254799
DOX-DMPA
Yes
Omar Mamdouh Shaaban, Assiut University
Omar Mamdouh Shaaban
Not Provided
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
Assiut University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP