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

• Sponsor: Omar Mamdouh Shaaban (Other)
• Overall Status: Completed
• CT.gov ID: NCT01254799
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 1.9

Study Details

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".

Condition or Disease	Intervention/Treatment	Phase
Uterine Hemorrhage	Drug: Doxycycline; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Doxycycline in Treatment of Bleeding With DMPA: a Double Blinded Randomized Controlled Trial
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Women in this arm will receive identical Placebo capsules twice daily for 5 days	Drug: Placebo; Placebo capsules twice daily for 5 days
Active Comparator: Doxycycline Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days	Drug: Doxycycline; 100 mg Doxycycline capsules twice daily for 5 days

Outcome Measures

Primary Outcome Measures

1. Stoppage of bleeding within 7 days [7 days from starting of tretment]

Secondary Outcome Measures

1. Number of days needed to stop a current attack of bleeding [1 month]

2. Next bleeding free interval [3 month]

3. Uterine bleeding patterns in the next 3 months after treatment [3 months]

4. Women satisfaction with the treatment she received [3 months]

5. Side effects encountered during treatment [5 days]

6. Discontinuation of the DMPA and its reason [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

• Omar Mamdouh Shaaban

Investigators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Mamdouh Shaaban, Dr, Assiut University
• ClinicalTrials.gov Identifier: NCT01254799
• Other Study ID Numbers: DOX-DMPA
• First Posted: Dec 7, 2010
• Last Update Posted: Nov 28, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Uterine Hemorrhage; Hemorrhage; Doxycycline

Study Results

No Results Posted as of Nov 28, 2011