NCT02626208

Brief Summary

This clinical trial investigates a new vaginal delivery system made of silicone rubber, containing Nestorone®, a 19-nor progesterone derivative and a low dose of serum estradiol (E2). The investigators plan to evaluate one-month data on the serum estradiol (E2) levels of three different contraceptive vaginal rings that contain a fixed dose of NES and escalating doses (75 µg/day, 100 µg/day, or 200 µg/day) of estradiol as the basis for selecting a CVR for a larger contraceptive efficacy trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

November 10, 2015

Last Update Submit

August 11, 2017

Conditions

Suppression of Ovulation

Keywords

Contraceptive vaginal ring

Outcome Measures

Primary Outcomes (1)

  • Change in serum estradiol (E2) levels of three different contraceptive vaginal rings

    Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)

Secondary Outcomes (3)

  • Change in progesterone levels

    Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)

  • Vaginal bleeding- amount and frequency

    Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)

  • Adverse event

    Assessments will be taken before insertion of the study ring (Day 1); Day 4 or ; Twice weekly during study ring use (approximately Days 7 or 8, 11 or 12, 14 or 15, 18 or 19, 21 or 22, 25 or 26) and at removal of study ring (Day 28-30)

Study Arms (3)

Nestorone®/ Estradiol 75

EXPERIMENTAL

Device: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 75 ug/day of estradiol

Device: Nestorone®/Estradiol Contraceptive Vaginal Ring

Nestorone®/Estradiol 100

EXPERIMENTAL

Device: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 100 ug/day of estradiol

Device: Nestorone®/Estradiol Contraceptive Vaginal Ring

Nestorone®/ Estradiol 200

EXPERIMENTAL

Device: Nestorone®/Estradiol Contraceptive Vaginal Ring with 200 mcg/day of NES and 200 ug/day of estradiol

Device: Nestorone®/Estradiol Contraceptive Vaginal Ring

Interventions

Nestorone®/Estradiol Contraceptive Vaginal RingDEVICE

Three arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol

Nestorone®/ Estradiol 200Nestorone®/ Estradiol 75Nestorone®/Estradiol 100

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general overall health with no chronic medical conditions that result in periodic exacerbations that require significant medical care.
  • Age 18-39 years, inclusive, at the enrollment visit.
  • Have a regular menstrual cycle 21-35 days in duration when not using hormonal contraception
  • Have an intact uterus and both ovaries.
  • Able and willing to comply with the protocol and sign an informed consent.
  • Consistent use of effective contraception during the preceding cycle (note: women who use oral, transdermal, vaginal, implantable or intrauterine hormonal contraceptives in the preceding cycle must have discontinued at least 7 days prior to start of treatment and not had unprotected intercourse since discontinuing the method).
  • Not at high risk for pregnancy, defined as consistently using a non-hormonal method of contraception (including Copper IUDs); have a surgically sterile male partner with a vasectomy; be abstinent; or be in a same-sex relationship from the start of treatment through study exit (including recovery period).
  • Have a negative pregnancy test at the admission visit.
  • Have a diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤135 mm Hg after 5 minutes rest in sitting position at the admission visit.
  • Willing to abstain from use of non-water based vaginal lubricant during the study.

You may not qualify if:

  • 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 study site.
  • Known hypersensitivity to progestins or estrogen.
  • 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.
  • History of thrombosis or embolism OR any other personal or family history which in the opinion of the investigator suggests increased risk.
  • History of stroke.
  • Known or suspected carcinoma of the breast.
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
  • Undiagnosed abnormal genital bleeding.
  • Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use.
  • Hepatic adenomas or carcinomas.
  • Known or suspected pregnancy.
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of California, Davis

Sacramento, California, 95817, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Oregon Health & Science Unit

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah

Salt Lake City, Utah, 84106, United States

Location

Eastern Virginia Medical School (EVMS)

Norfolk, Virginia, 23507, United States

Location

Related Links

Study Officials

  • Diana Blithe, MD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

December 10, 2015

Study Start

January 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

US(7)