Norplant and Irregular Bleeding/Spotting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2003 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00064766
First received: July 11, 2003
Last updated: June 23, 2005
Last verified: May 2003
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 50
Study Start Date: February 2003
Estimated Study Completion Date: February 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064766

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         
Sponsors and Collaborators
Investigators
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:
Uterine Hemorrhage
Hemorrhage
Periodontal Diseases
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
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 July 28, 2014