Overview

This trial is active, not recruiting.

Condition breakthrough bleeding
Treatment doxycycline
Sponsor University of Hawaii
Collaborator Charles Drew University of Medicine and Science
Start date November 2011
End date June 2012
Trial size 14 participants
Trial identifier NCT01469585, UH DOXY RTRN

Summary

The purpose of this study is to compare the effects (good and bad) of subantimicrobial dose doxycycline on the irregular bleeding women experience when taking continuous oral contraceptive pills. This research is being done because currently, there is no effective treatment for this condition. Findings from this study could help to decrease the side effects of birth control pills and decrease unplanned pregnancies.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.
doxycycline Oracea
40 mg orally at the start of cycle 3 (study day 57) for 28 days.
(No Intervention)
Women will take only the continuous oral contraceptive.

Primary Outcomes

Measure
Determine the effect of combined oral contraceptives on endometrial MMP expression.
time frame: 49 days

Secondary Outcomes

Measure
Determine the effect of sub-antimicrobial doxycycline on MMP expression and activity in continuous oral contraceptive users.
time frame: 84 days

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - Women between the ages 18 and 45 who are ovulatory as demonstrated by a pre-treatment Progesterone (P) greater than or equal to 3.0 ng/mL prior to oral contraceptive use Exclusion Criteria: - Women with any absolute contraindications to EE and LNG; - Women who are pregnant, breastfeeding or have POS; - Use of oral contraceptives, patch, ring, intrauterine or implantable hormonal contraception within 4-weeks; - Medroxyprogesterone acetate use within six months; - Current use of drugs that interfere with sex steroid metabolism.

Additional Information

Official title Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs
Principal investigator Bliss Kaneshiro, MD, MPH
Description Continuous oral contraceptive administration entails women taking hormonally active pills for 28 days without a seven day placebo week to avoid hormonal withdrawal bleeding. Unfortunately, with continuous administration, timed, regular bleeding can be replace by irregular, unscheduled bleeding, which often leads to dissatisfaction, discontinuation and the possibility of unplanned pregnancy. MMPs, a group of zinc-dependant proteases, are hypothesized to play a role in endometrial degradation. The purpose of this study is to describe the expression of MMPs in endometrial biopsy (EMB) specimens collected 1) prior to initiating oral contraceptives 2) while taking cyclic oral contraceptive 3) while taking continuous oral contraceptives and 4) while taking continuous oral contraceptives along with sub-antimicrobial doxycycline.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by University of Hawaii.