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Norplant and Irregular Bleeding/Spotting

NCT ID: NCT00064766

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-02-28

Brief Summary

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Irregular or prolonged menstrual bleeding and/or spotting are common side effects in patients using progestin-only hormonal contraception such as levonorgestrel implants (Norplant). Doxycycline, a drug approved by the Food and Drug Administration (FDA) to treat gum disease, may reduce the occurrence of uterine bleeding and spotting in women who use Norplant. This study will evaluate the effects of doxycycline on uterine bleeding/spotting in women using Norplant.

Detailed Description

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A high percentage of women using progestin-only contraception experience breakthrough bleeding (BTB) and spotting that causes impaired lifestyle and results in decreased compliance with this contraceptive method. There is a need for an effective, low-cost, easily adapted treatment to reduce the bleeding and spotting in progestin-only contraceptives. The molecular environment of the endometrium of women with BTB and spotting contains abnormally high levels of pro-inflammatory cytokines (TNF-alpha and IL-1 beta) and abnormally high levels of proteases (matrix metalloproteinases \[MMPs\] and neutrophil elastase), which prevent normal tissue repair. Doxycycline (DOX) is an inexpensive, FDA approved antibiotic that inhibits MMPs and reduces nitric oxide synthesis. This study will evaluate DOX treatment of progestin-only contraceptive induced BTB and spotting, characterize the endometrial molecular biologic changes that occur in DOX treated patients, and determine the effect of Norplant on sexual functioning and testosterone levels.

All participants in this study will receive Norplant. Participants will then be randomized to receive either DOX (20 mg twice a day) or placebo for 6 months. Participants will have 9 study visits during the 24 weeks of the study. Study visits will include a medical history, physical exam, and blood and urine tests. Participants will also have three periodontal evaluations and three endometrial biopsies. At the end of the study, participants may choose to have the Norplant implant removed if they wish to discontinue Norplant use; otherwise the implant may remain in for up to 5 years.

Conditions

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Endometrial Bleeding Periodontal Disease

Keywords

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Norplant Periodontal disease Endometrial bleeding Progestin-induced endometrial bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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doxycycline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Regular menstrual periods for the last 2 cycles
* Currently not using hormonal contraceptives, including oral contraceptives, patch, ring, or Norplant in 2 months prior to study entry, or Depo-Provera in 12 months prior to study entry
* Currently not using tetracycline-class antibiotics
* Normal Pap smear

Exclusion Criteria

* Pregnancy or breastfeeding within 2 months of study entry
* Chronic migraine headaches
* Uncontrolled high blood pressure
* Untreated sexually transmitted diseases
* Alcoholism or drug abuse within 12 months of study entry
* Insulin dependent diabetes
* Liver, kidney, or gallbladder disease
* Participation in another clinical trial within 30 days of study entry
* History of cancer
* History of blood clots, strokes, or heart disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Principal Investigators

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David F Archer, MD

Role: PRINCIPAL_INVESTIGATOR

CONRAD Clinical Research Center, Eastern Virginia Medical School

Locations

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CONRAD Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Wendi A Gobhardt, RN, BSN

Role: primary

Joann Cooper, RN

Role: backup

Other Identifiers

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NIH 1 R01 HD43175-01

Identifier Type: -

Identifier Source: secondary_id

R01HD043175

Identifier Type: NIH

Identifier Source: org_study_id

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