Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
Condition: Contraception: Optional Applicator for Insertion of Vaginal Ring
Intervention: Placebo vaginal ring; Single-use, non-sterile applicator
Intervention description: Drug-free placebo vaginal ring; Single-use, non-sterile, plastic applicator for insertion of vaginal ring.
Intervention MeSH terms: NuvaRing; Ethinyl Estradiol; Desogestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

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.