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Doxycycline 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
Omar Mamdouh Shaaban
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Hemorrhage

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

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

First Posted
December 6, 2010
Last Updated
November 25, 2011
Sponsor
Omar Mamdouh Shaaban
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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

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

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