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

Phase 3

Completed

• Conditions: Uterine Hemorrhage
• Interventions: Drug: Placebo; Drug: Doxycycline

• Registration Number: NCT01254799
• Lead Sponsor: Omar Mamdouh Shaaban

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".

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-09
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Study Completion: 2011-01
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-25
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Women in this arm will receive identical Placebo capsules twice daily for 5 days
Doxycycline	Doxycycline	Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days

Primary Outcome Measures

Name	Time	Method
Stoppage of bleeding within 7 days	7 days from starting of tretment

Secondary Outcome Measures

Name	Time	Method
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
Discontinuation of the DMPA and its reason	3 months

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt