A Study of Continuous Oral Contraceptives and Doxycycline

Summary

The purpose of this study is to learn if the study drug, doxycycline, can decrease the amount of unplanned vaginal bleeding that women commonly experience when taking combined oral contraception (COC)- pills with estrogen and progestin - in a continuous fashion - no hormone-free week. The study drug, doxycycline, is an antibiotic used commonly for many conditions (i.e. acne, Chlamydia infections, pneumonia) and can be safely used on a daily basis. Doxycycline has been shown to decrease unplanned vaginal bleeding in progestin-only contraception but has not been studied in combined hormonal contraception.

Conditions

• Contraceptives, Oral

Interventions

DRUG

Lybrel

All women enrolled in the study will take the same daily low dose oral contraceptive (20-mcg EE/90 mcg LNG) dosed in a continuous fashion.

DRUG

Doxycycline

100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline.

DRUG

Oracea

40-mg tablet daily for 84 days

DRUG

Placebo

Placebo pill orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of placebo

DRUG

Doxycycline 100bid x5 days at the time of bleeding

Doxycycline 100 mg orally twice a day for five days starting on the first day of breakthrough bleeding. This regimen will be repeated if bleeding persists or recurs seven days after completing five-day course of doxycycline

DRUG

Subantimicrobial doxycycline daily

Subantimicrobial dose doxycycline 40mg daily for the first 84 days of the study

DRUG

placebo daily

Placebo daily for the first 84 days of the study

Sponsors & Collaborators

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• Jeffrey T Jensen, M.D, MPH · Oregon Health and Science University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-05-31

Primary Completion

2010-01-31

Completion

2011-05-31

Countries

• United States

Study Locations