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

NCT ID: NCT01254799

Last Updated: 2011-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Uterine Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Women in this arm will receive identical Placebo capsules twice daily for 5 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules twice daily for 5 days

Doxycycline

Women in this arm will receive 100 mg doxycycline capsules twice daily for 5 days

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

100 mg Doxycycline capsules twice daily for 5 days

Interventions

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Doxycycline

100 mg Doxycycline capsules twice daily for 5 days

Intervention Type DRUG

Placebo

Placebo capsules twice daily for 5 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Omar Mamdouh Shaaban

OTHER

Sponsor Role lead

Responsible Party

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Omar Mamdouh Shaaban

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hany Abdel-Aleem, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Omar M Shaaban, MD

Role: STUDY_DIRECTOR

Assiut University

Mahmoud Abdel=Aleem, MD

Role: STUDY_CHAIR

Assiut University

Gehian N Fetih, PH.D

Role: STUDY_CHAIR

Faculty of Pharmacy, Assiut University

Locations

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Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 22325113 (View on PubMed)

Other Identifiers

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DOX-DMPA

Identifier Type: -

Identifier Source: org_study_id