- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00064766
Norplant and Irregular Bleeding/Spotting
A Prospective Randomized Clinical Trial of Doxycycline 20mg Twice a Day Versus Placebo on the Bleeding and Spotting in Women After Insertion of a Levonorgestrel Implant (Norplant) Protocol #2002-1
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Recruiting
- CONRAD Clinical Research Center, Eastern Virginia Medical School
-
Contact:
- Wendi A Gobhardt, RN, BSN
- Phone Number: 757-446-8487
- Email: gobharwa@evms.edu
-
Contact:
- Joann Cooper, RN
- Phone Number: 757-446-8487
- Email: cooperjk@evms.edu
-
Principal Investigator:
- David F Archer, MD
-
Sub-Investigator:
- George Kovalevsky, MD
-
Sub-Investigator:
- Susan A Ballagh, MD
-
Sub-Investigator:
- Gayle McCombs, RHD, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- Principal Investigator: David F Archer, MD, CONRAD Clinical Research Center, Eastern Virginia Medical School
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HD043175 (U.S. NIH Grant/Contract)
- NIH 1 R01 HD43175-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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