Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263341
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2005-12-06
Brief Title:
Safety and Efficacy of a Contraceptive Vaginal Ring Delivering Nestorone and Ethinyl Estradiol
Sponsor:
Population Council
Organization:
Population Council
Study Overview
Official Title:
A Multicenter Open-label Study on the Efficacy Cycle Control and Safety of a Contraceptive Vaginal Ring Delivering a Daily Dose of 150 ug of Nestorone and 15 ug of Ethinyl Estradiol
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this 1-year study is to evaluate the efficacy and safety of a new contraceptive vaginal ring CVR delivering low doses of Nestorone NES a new nonandrogenic progestin and ethinyl estradiol EE an estrogen used in oral contraceptives The CVR which is made of silicone rubber is designed to be used for 1 year 13 menstrual cycles before replacement is required
Detailed Description:
The objective of this study is to evaluate the contraceptive efficacy cycle control and safety of a reusable CVR delivering low daily doses of NES and EE for a 1-year 13-cycle period
Nestorone is a potent nonandrogenic 19-norprogesterone derivative which is not active when given orally but is highly active when delivered via non-oral delivery systems such as CVRs implants or transdermal preparations The high potency of NES makes it an excellent candidate for use in contraceptive delivery systems designed to be effective for prolonged periods This characteristic of Nestorone has been utilized in the design of a contraceptive vaginal ring that releases low daily doses of both NES and EE and is effective for a 1-year 13-cycle period The NESEE vaginal ring is a long-acting contraceptive device but unlike other long-term methods it use is controlled by the woman without the need for medical intervention
The efficacy of NESEE vaginal ring in preventing pregnancy during a 1-year 13-cycle period will be studied in women who have regular sexual activity and use no other form of contraception The Pearl index for all women 18-40 and Kaplan-Meier life table analyses will be assessed for all subjects and for subjects 35 years and will provide supportive analyses for demonstrating efficacy Pearl indices will be based on all cycles and on all cycles for which back-up contraception is not used
The number of bleedingspotting days per cycle or reference period will be used to evaluate cycle control Safety will be evaluated by regular assessments of blood pressure pulse and body weight and by laboratory testing and Pap smears at screening and termination and by the frequencies of adverse events and serious adverse events Additional safety evaluations will be obtained in a companion Phase 3 study conducted by the NIH Protocol CCN006 with three substudies to evaluate 1 the effect of treatment on 4 hepatic proteins that may be associated with a risk for thromboembolism 2 the effect of reusing the same CVR for 13 consecutive cycles on vaginal flora and the risk of infection and 3 the effect of vaginal delivery of NES and EE on the endometrium
A nested pharmacokineticspharmacodynamicssafety study is also being conducted in a subset of 39 patients Blood samples are drawn during study cycles 1 3 and 13 in order to assess ovulation suppression measured by serum progesterone concentration and the pharmacokinetics of NES and EE
Nestorone is a potent nonandrogenic 19-norprogesterone derivative which is not active when given orally but is highly active when delivered via non-oral delivery systems such as CVRs implants or transdermal preparations The high potency of NES makes it an excellent candidate for use in contraceptive delivery systems designed to be effective for prolonged periods This characteristic of Nestorone has been utilized in the design of a contraceptive vaginal ring that releases low daily doses of both NES and EE and is effective for a 1-year 13-cycle period The NESEE vaginal ring is a long-acting contraceptive device but unlike other long-term methods it use is controlled by the woman without the need for medical intervention
The efficacy of NESEE vaginal ring in preventing pregnancy during a 1-year 13-cycle period will be studied in women who have regular sexual activity and use no other form of contraception The Pearl index for all women 18-40 and Kaplan-Meier life table analyses will be assessed for all subjects and for subjects 35 years and will provide supportive analyses for demonstrating efficacy Pearl indices will be based on all cycles and on all cycles for which back-up contraception is not used
The number of bleedingspotting days per cycle or reference period will be used to evaluate cycle control Safety will be evaluated by regular assessments of blood pressure pulse and body weight and by laboratory testing and Pap smears at screening and termination and by the frequencies of adverse events and serious adverse events Additional safety evaluations will be obtained in a companion Phase 3 study conducted by the NIH Protocol CCN006 with three substudies to evaluate 1 the effect of treatment on 4 hepatic proteins that may be associated with a risk for thromboembolism 2 the effect of reusing the same CVR for 13 consecutive cycles on vaginal flora and the risk of infection and 3 the effect of vaginal delivery of NES and EE on the endometrium
A nested pharmacokineticspharmacodynamicssafety study is also being conducted in a subset of 39 patients Blood samples are drawn during study cycles 1 3 and 13 in order to assess ovulation suppression measured by serum progesterone concentration and the pharmacokinetics of NES and EE
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