Doxycycline in Treatment of Bleeding With Depot Medroxyprogesterone Acetate (DMPA)
DOX-DMPA
1 other identifier
interventional
68
1 country
1
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2008
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedNovember 28, 2011
November 1, 2011
2.7 years
December 6, 2010
November 25, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Stoppage of bleeding within 7 days
7 days from starting of tretment
Secondary Outcomes (6)
Number of days needed to stop a current attack of bleeding
1 month
Next bleeding free interval
3 month
Uterine bleeding patterns in the next 3 months after treatment
3 months
Women satisfaction with the treatment she received
3 months
Side effects encountered during treatment
5 days
- +1 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORWomen in this arm will receive identical Placebo capsules twice daily for 5 days
Doxycycline
ACTIVE COMPARATORWomen in this arm will receive 100 mg doxycycline capsules twice daily for 5 days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Asyut, Asyut Governorate, Egypt
Related Publications (1)
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.
PMID: 22325113DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 6, 2010
First Posted
December 7, 2010
Study Start
January 1, 2008
Primary Completion
September 1, 2010
Study Completion
January 1, 2011
Last Updated
November 28, 2011
Record last verified: 2011-11