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

Omar Mamdouh Shaaban

Status and phase: Completed; Phase 3

Conditions: Uterine Hemorrhage

Treatments: Drug: Placebo; Drug: Doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT01254799

DOX-DMPA

Details and patient eligibility

About

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".

Enrollment: 68 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Doxycycline

Active Comparator group

Description:

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

Treatment:

Drug: Doxycycline