Norplant and Irregular Bleeding/Spotting
Recruitment status was Recruiting
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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
- 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
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00064766 History of Changes |
| Other Study ID Numbers: | R01HD43175, NIH 1 R01 HD43175-01 |
| Study First Received: | July 11, 2003 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
Norplant Periodontal disease Endometrial bleeding Progestin-induced endometrial bleeding |
Additional relevant MeSH terms:
|
Hemorrhage Periodontal Diseases Adenoma Uterine Hemorrhage Pathologic Processes Mouth Diseases Stomatognathic Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Diseases Genital Diseases, Female Doxycycline Doxycycline hyclate |
Levonorgestrel Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimalarials Antiprotozoal Agents Antiparasitic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 22, 2013