Back to resultsDoxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA) (DOX-DMPA)
Primary Purpose
Uterine Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Doxycycline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Women under DMPA contraception for at least one month.
- 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.
- Women's ability to keep an accurate menstrual diary for the study.
Exclusion Criteria:
- Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
- Patients with already diagnosed local gynecological abnormality.
- Women receiving treatment for bleeding within the last one month.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Doxycycline
Arm Description
Women in this arm will receive identical Placebo capsules twice daily for 5 days
Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days
Outcomes
Primary Outcome Measures
Stoppage of bleeding within 7 days
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01254799
First Posted
December 6, 2010
Last Updated
November 25, 2011
Sponsor
Omar Mamdouh Shaaban
1. Study Identification
Unique Protocol Identification Number
NCT01254799
Brief Title
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
Acronym
DOX-DMPA
Official Title
Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Omar Mamdouh Shaaban
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Women in this arm will receive identical Placebo capsules twice daily for 5 days
Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Intervention Description
100 mg Doxycycline capsules twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules twice daily for 5 days
Primary Outcome Measure Information:
Title
Stoppage of bleeding within 7 days
Time Frame
7 days from starting of tretment
Secondary Outcome Measure Information:
Title
Number of days needed to stop a current attack of bleeding
Time Frame
1 month
Title
Next bleeding free interval
Time Frame
3 month
Title
Uterine bleeding patterns in the next 3 months after treatment
Time Frame
3 months
Title
Women satisfaction with the treatment she received
Time Frame
3 months
Title
Side effects encountered during treatment
Time Frame
5 days
Title
Discontinuation of the DMPA and its reason
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women under DMPA contraception for at least one month.
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.
Women's ability to keep an accurate menstrual diary for the study.
Exclusion Criteria:
Lactating women for the fear of the effect of tetracycline on the breast-fed infant.
Patients with already diagnosed local gynecological abnormality.
Women receiving treatment for bleeding within the last one month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Abdel-Aleem, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Omar M Shaaban, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud Abdel=Aleem, MD
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gehian N Fetih, PH.D
Organizational Affiliation
Faculty of Pharmacy, Assiut University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
22325113
Citation
Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Fetih GN. Doxycycline in the treatment of bleeding with DMPA: a double-blinded randomized controlled trial. Contraception. 2012 Sep;86(3):224-30. doi: 10.1016/j.contraception.2012.01.003. Epub 2012 Feb 9.
Results Reference
derived
Learn more about this trial
Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
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