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Completed

NCT Number: NCT01254799

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

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".

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Key information

Conditions

Uterine Hemorrhage Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doxycycline

Drug

100 mg Doxycycline capsules twice daily for 5 days

Placebo

Drug

Placebo capsules twice daily for 5 days

Primary outcomes

  1. Stoppage of bleeding within 7 days

    Time frame: 7 days from starting of tretment

Secondary outcomes

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

    Time frame: 1 month

  2. Next bleeding free interval

    Time frame: 3 month

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

    Time frame: 3 months

  4. Women satisfaction with the treatment she received

    Time frame: 3 months

  5. Side effects encountered during treatment

    Time frame: 5 days

  6. Discontinuation of the DMPA and its reason

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Omar Mamdouh Shaaban

Other

Registry information

Official study title

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

Acronym: DOX-DMPA

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Nov 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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