MedDataX Logo

Oral Contraceptives and Subantimicrobial Doxycycline: Effect on Endometrial Matrix Metalloproteinases

NCT ID: NCT01469585

Last Updated: 2020-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breakthrough Bleeding

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

continuous oral contraceptives Matrix Metalloproteinase expression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sub-antimicrobial doxycycline

Women will take sub-antimicrobial doxycyline in addition to the continuous oral contraceptive pill.

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

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

Continuous Oral Contraceptive Pill

Women will take only the continuous oral contraceptive.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxycycline

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oracea

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charles Drew University of Medicine and Science

OTHER

Sponsor Role collaborator

Meharry Medical College

OTHER

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bliss Kaneshiro

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bliss Kaneshiro, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UH DOXY RTRN

Identifier Type: -

Identifier Source: org_study_id