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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00064766 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Bleeding Periodontal Disease |
Drug: doxycycline |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | February 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Exclusion criteria
Contacts and Locations| United States, Virginia | |
| CONRAD Clinical Research Center, Eastern Virginia Medical School | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Wendi A Gobhardt, RN, BSN 757-446-8487 gobharwa@evms.edu | |
| Contact: Joann Cooper, RN 757-446-8487 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 | |
| Principal Investigator: | David F Archer, MD | CONRAD Clinical Research Center, Eastern Virginia Medical School |
More Information
| Study ID Numbers: | R01HD43175, NIH 1 R01 HD43175-01 |
| Study First Received: | July 11, 2003 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00064766 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Norplant Periodontal disease Endometrial bleeding Progestin-induced endometrial bleeding |
|
Mouth Diseases Anti-Infective Agents Antiprotozoal Agents Uterine Hemorrhage Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Uterine Diseases Reproductive Control Agents Hemorrhage Pharmacologic Actions |
Genital Diseases, Female Antimalarials Anti-Bacterial Agents Antiparasitic Agents Periodontal Diseases Pathologic Processes Levonorgestrel Therapeutic Uses Contraceptives, Oral, Synthetic Stomatognathic Diseases Doxycycline |