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Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs


N/A
18 Years
45 Years
Open (Enrolling)
Female
Breakthrough Bleeding

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Trial Information

Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial MMPs


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Determine the effect of combined oral contraceptives on endometrial MMP expression.

Outcome Description:

Baseline MMP expression will be determined on day 19-21 of cycle 1. During cycle 2, when women are taking the cyclic oral contraceptive, the EMB will be performed between cycle day 19-21 (study day 47-49), prior to endometrial degradation.

Outcome Time Frame:

49 days

Safety Issue:

No

Principal Investigator

Bliss Kaneshiro, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Hawaii John A. Burns School of Medicine Department of Obstetrics and Gynecology

Authority:

United States: Federal Government

Study ID:

UH DOXY RTRN

NCT ID:

NCT01469585

Start Date:

November 2011

Completion Date:

June 2012

Related Keywords:

  • Breakthrough Bleeding
  • continuous oral contraceptives
  • MMP expression
  • Hemorrhage
  • Metrorrhagia
  • Adenoma

Name

Location
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826