Skip to main content
OpenTrials
Completed

NCT Number: NCT01469585

Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, 96826, United States

About this study

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.

Matrix Metalloproteinases, 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 Matrix Metalloproteinases in endometrial biopsy 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.

Who can participate

Healthy volunteers accepted: Yes

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

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 ethinyl estradiol and levonorgestrel;
  • Women who are pregnant or breastfeeding
  • 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.

Treatment and study plan

Doxycycline

Drug

40 mg orally at the start of cycle 3 (study day 57) for 28 days.

Other names: Oracea

Primary outcomes

  1. Endometrial Matrix Metalloproteinase Expression by Gel Densitometry

    Time frame: 49 days

    Baseline Matrix Metalloproteinase expression (activity level) will be determined on day 19-21 of cycle 1. During cycle 2, when women are taking the cyclic oral contraceptive, the endometrial biopsy will be performed between cycle day 19-21 (study day 47-49), prior to endometrial degradation and activity level will be noted. Of note, the outcome is MMP activity level, not a change in level.

Secondary outcomes

  1. Matrix Metalloproteinase Expression and Activity by Gel Densitometry

    Time frame: 84 days

    Based on doxycycline's action as an Matrix Metalloproteinase inhibitor, it is hypothesized that Matrix Metalloproteinase expression and activity level will be decreased in women taking sub-antimicrobial doxycycline compared to women on continuous oral contraceptives only. The outcome is activity level (not a change in activity level)

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • Charles Drew University of Medicine and Science
  • Meharry Medical College

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2011
Registry last updated
Dec 17, 2020

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.

Published trials that share one or more normalized conditions with this study.