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

NCT ID: NCT02275546

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-11
• Study Completion Date: 2015-04-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Applicator→No Applicator (manual)

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

Group Type: EXPERIMENTAL

Placebo vaginal ring

Intervention Type: DRUG

Drug-free placebo vaginal ring

Single-use, non-sterile applicator

Intervention Type: DEVICE

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

No applicator (manual)→Applicator

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

Group Type: EXPERIMENTAL

Placebo vaginal ring

Intervention Type: DRUG

Drug-free placebo vaginal ring

Single-use, non-sterile applicator

Intervention Type: DEVICE

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

Interventions

Placebo vaginal ring

Drug-free placebo vaginal ring

Intervention Type: DRUG

Single-use, non-sterile applicator

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

Intervention Type: DEVICE

Other Intervention Names

NuvaRing; NuvaRing Applicator

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: RESULT

PMID: 27207028 (View on PubMed)

Other Identifiers

8342A-063

Identifier Type: -

Identifier Source: org_study_id