Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)

NCT02275546 | Completed Phase 3 Results

• 1 other identifier: 8342A-063
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the performance and safe use of the vaginal ring applicator as an optional aid for insertion of a placebo vaginal ring into the vagina in healthy women

Conditions

Contraception: Optional Applicator for Insertion of Vaginal Ring

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Successful Ring Insertion

  Participants completed a Post-Insertion Questionnaire in which they were asked about their experience inserting the vaginal ring. Their answers were recorded and evaluated.

  Day 1 (immediately after vaginal ring insertion)

• Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion

  Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.

  Up to 48 hours after vaginal ring insertion

Study Arms (2)

Applicator→No Applicator (manual)

EXPERIMENTAL

Treatment period 1: Participants will use applicator to insert vaginal ring. Treatment period 2: Participants will manually insert vaginal ring using fingers only.

Drug: Placebo vaginal ring; Device: Single-use, non-sterile applicator

No applicator (manual)→Applicator

EXPERIMENTAL

Treatment period 1: Participants will manually insert vaginal ring using fingers only. Treatment period 2: Participants will use applicator to insert vaginal ring.

Drug: Placebo vaginal ring; Device: Single-use, non-sterile applicator

Interventions

Placebo vaginal ring DRUG

Drug-free placebo vaginal ring

Also known as: NuvaRing

Applicator→No Applicator (manual); No applicator (manual)→Applicator

Single-use, non-sterile applicator DEVICE

Single-use, non-sterile, plastic applicator for insertion of vaginal ring.

Also known as: NuvaRing Applicator

Applicator→No Applicator (manual); No applicator (manual)→Applicator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy, non-pregnant, pre-menopausal female who is not using NuvaRing.
• must meet one of the two following criteria: 1) has not taken a combined hormonal contraceptives for at least 3 months prior to screening and has normal predictable menstrual cycles ranging from 26 to 35 days in length with no history of intermenstrual bleeding in the past 6 months; or 2) has been taking a combined hormonal contraceptive for \>3 months and has not experienced unscheduled bleeding for the past 3 months.
• willing to abstain from vaginal penetration, including during sexual intercourse and masturbation, from the time of randomization (Visit 2) to the end of the follow-up period.
• willing to abstain from vaginal penetration with any objects other than the applicator and placebo rings (including but not limited to tampons, douching, use of vaginal applicators for medication, medication, diaphragms, cervical caps, male and female condoms, lubricants, sex toys) from the time of randomization (Visit 2) to the end of the follow-up period.
• good physical and mental health, based upon the medical judgment of the investigator.

You may not qualify if:

• current use or has used within past 3 months any of the following: NuvaRing, progestin-only contraceptives (including pills, injection, or implant), oral or transdermal combined hormonal contraceptives with extended or continuous hormonal regimens that prevent monthly withdrawal bleeding by omitting monthly progestin-free intervals. Note: Current use of oral or transdermal combined hormonal contraceptives with 4 to 7 progestin-free days per 28-day cycle for \>3 months is permitted.
• has stopped use of any hormonal contraceptive, including NuvaRing, \<3 months prior to screening; previous use (≥3 months prior to screening) is permitted.
• history of difficulty retaining NuvaRing in the vagina and therefore could not continue on it as a contraceptive method or difficulty retaining other products (e.g., tampons) in the vagina.
• is pregnant or within 2 months of last pregnancy outcome (delivery, spontaneous or induced abortion, medical or surgical management of ectopic pregnancy).
• is breastfeeding.
• diagnosed or treated for a sexually transmitted disease within the past 6 months.
• current complaints of vaginal or vulvar irritation, discomfort, abnormal bleeding/spotting, or abnormal discharge.
• abnormal cervical Pap smear documented within 12 months of screening.
• genital herpes outbreak in the past 3 years.
• has received any investigational drug or device in the 30 days prior to screening and/or plans to receive any investigational drug or device at any time up to the last protocol-required visit.
• known current gynecological disorder which, in the opinion of the investigator, interferes with the objectives of the study.
• known allergy/sensitivity or contraindication to the investigational product (applicator) or ethylene vinyl acetate.
• current or recent history (within the last six months) of drug or alcohol abuse or dependence.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Feldman R, Frenkl TL, Yacik C, Wang Y, Fox MC. Safety and efficacy of the NuvaRing(R) Applicator in healthy females: a multicenter, open-label, randomized, 2-period crossover study. Contraception. 2016 Oct;94(4):362-5. doi: 10.1016/j.contraception.2016.04.017. Epub 2016 May 17.

  PMID: 27207028 RESULT

MeSH Terms

Interventions

NuvaRing

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: December 11, 2014
• Primary Completion: April 10, 2015
• Study Completion: April 10, 2015
• Last Updated: May 17, 2024
• Results First Posted: April 28, 2016

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share