Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064766
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-07-11
Brief Title:
Norplant and Irregular BleedingSpotting
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2003-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Irregular or prolonged menstrual bleeding andor 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 bleedingspotting in women using Norplant
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH 1 R01 HD43175-01 | None | None | None |