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

Uterine Hemorrhage Clinical Trial

— DOX-DMPA  

Official title:

Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254799
• Other study ID #: DOX-DMPA
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2010
• Last updated: November 25, 2011
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Hemorrhage

Intervention

Drug:
• Doxycycline
100 mg Doxycycline capsules twice daily for 5 days
• Placebo
Placebo capsules twice daily for 5 days

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Omar Mamdouh Shaaban

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stoppage of bleeding within 7 days		7 days from starting of tretment	No
Secondary	Number of days needed to stop a current attack of bleeding		1 month	No
Secondary	Next bleeding free interval		3 month	No
Secondary	Uterine bleeding patterns in the next 3 months after treatment		3 months	No
Secondary	Women satisfaction with the treatment she received		3 months	No
Secondary	Side effects encountered during treatment		5 days	Yes
Secondary	Discontinuation of the DMPA and its reason		3 months	No