Clinical Trials/NCT01586000

NCT01586000

Completed

Phase 2

A Dose-finding Study to Evaluate the Effect of a Contraceptive Vaginal Ring, Releasing Nestorone® and Estradiol, on Cycle Control, Ovulation Inhibition, and Pharmacokinetics in Normal Cycling Women

Kimberly Myer8 sites in 1 country197 target enrollmentMarch 1, 2012

ConditionsSuppression of Ovulation

Interventions10 µg/day E2 with NES 200® µg/day 20 µg/day E2 with NES 200® µg/day 40 µg/day E2 with NES 200® µg/day

Drugs10 µg/day E2 with NES 200® µg/day 20 µg/day E2 with NES 200® µg/day 40 µg/day E2 with NES 200® µg/day

Overview

Phase: Phase 2
Intervention: 10 µg/day E2 with NES 200® µg/day
Conditions: Suppression of Ovulation
Sponsor: Kimberly Myer
Enrollment: 197
Locations: 8
Primary Endpoint: Number of Days Bleeding is Reported.
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This clinical trial is an experimental research study using a potential new form of birth control. Clinical trials include people who volunteer to take part in a study. Take your time to decide if you want to be part of this experimental research study. If you want to know more about this study first, ask the study doctor or study site staff. The investigators can also give you the study information written for doctors and clinic staff.

Registry

clinicaltrials.gov

Start Date

March 1, 2012

End Date

May 1, 2015

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Kimberly Myer

Responsible Party

Sponsor Investigator

Principal Investigator

Kimberly Myer

Program Director

Premier Research

Eligibility Criteria

Inclusion Criteria

•Women who meet all the following criteria are eligible for enrollment in the trial:
•Healthy women of reproductive age (18-39 years, inclusive, at the enrollment visit).
•Have a regular menstrual cycle that is 21-35 days in duration.
•Have intact uterus and both ovaries.
•Will be able and willing to comply with the protocol and sign an informed consent.
•Will not be at risk for pregnancy. They will be consistently using a non-hormonal method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the control period through study exit (including recovery period).
•Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes in sitting position.
•Willing to abstain from use of non-water based vaginal lubricant during the study.

Exclusion Criteria

•Women who meet any of the following criteria are not eligible for enrollment in the trial:
•Participating in another clinical trial involving an investigational product within the last 30 days (prior to screening) or planning to participate in another clinical trial during this study.
•Not living in the catchment area of the clinic.
•Known hypersensitivity to progestins or estrogen.
•All contraindications to combined estrogen-progestin contraceptive use including:
•Thrombophlebitis or thromboembolic disorders.
•Past personal history of deep vein thrombophlebitis or thromboembolic disorders.
•History of venous thrombosis or embolism in a first-degree relative \<55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the investigator, suggests use of a hormonal contraceptive could pose a significant risk.
•History of stroke.
•Known or suspected carcinoma of the breast.

Arms & Interventions

10 µg/day E2

Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days).

Intervention: 10 µg/day E2 with NES 200® µg/day

20 µg/day E2

Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days).

Intervention: 20 µg/day E2 with NES 200® µg/day

40 µg/day E2

Two consecutive 3-month (90-day) rings will be used continuously for six months (180 days).

Intervention: 40 µg/day E2 with NES 200® µg/day

Outcomes

Primary Outcomes

Number of Days Bleeding is Reported.

Time Frame: Three months

The primary outcome will be the number of days that bleeding or spotting is reported in the first 3 cycles (90 days) of treatment.

Secondary Outcomes

Area Under the Curve of NES and E2 at Specified Time Points(Visits 12, 32, and 41 (Treatment Period))
Changes From Baseline in ALT/SGPT (U/L)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in BUN (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Number of Subjects With Ovulation at During Each Cycle(Control Cycle 1, Treatment Cycles 2, 3, and 7, Recovery Cycle 8, up to 8 months)
Changes From Baseline in Albumin (g/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Calcium (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Glucose (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Total Bilirubin (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
The Safety of Administering 200 µg/Day of NES and One of Three Doses (10, 20, or 40 µg/Day) of E2 Delivered by CVR Continuously for 6 Months (180 Days).(Through Recovery Cycle 8, up to 8 months)
Number of Days Bleeding is Reported.(Three months)
Changes From Baseline in AST/SGOT (U/L)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Creatinine (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in GGT (U/L)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Total Protein (g/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in LDL Cholesterol (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Sodium (mmol/L)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in RBC (MIL/uL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Total Cholesterol (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in HDL Cholesterol (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Triglycerides (mg/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Chloride (mmol/L)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Potassium (mmol/L)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in WBC (THOU/uL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Hemoglobin (g/dL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Hematocrit (%)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Platelet Count (THOU/uL)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Basophils (%)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Eosinophils (%)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Lymphocytes (%)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Monocytes (%)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))
Changes From Baseline in Neutrophils (%)(Visit 41 (end of Treatment Cycle 7) compared to Visit 1 (Screening))