Contraception: Optional Applicator for Insertion of Vaginal RingPhase 3NCT02275546
Performance and Safety of Vaginal Ring Applicator in Healthy Females (MK-8342A-063)
A Phase 3 study testing Single-use, non-sterile applicator in people with Contraception: Optional Applicator for Insertion of Vaginal Ring, run by Organon and Co.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception: Optional Applicator for Insertion of Vaginal Ring
- What is being tested?
- Single-use, non-sterile applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2014to 10 Apr 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Multicenter, Open Label, Randomized, Two-period Crossover Study on the Insertion of MK-8342A (NuvaRing®) Placebo With and Without the Use of NuvaRing Applicator in Healthy Female Subjects
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
- Being tested
- Placebo vaginal ring, Single-use, non-sterile applicator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo vaginal ringDrug
Also called NuvaRing
Drug-free placebo vaginal ring
Single-use, non-sterile applicatorDevice
Also called NuvaRing Applicator
Single-use, non-sterile, plastic applicator for insertion of vaginal ring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo vaginal ring; Device: Single-use, non-sterile applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 48 hours after vaginal ring insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study start11 Dec 2014
- Primary completion10 Apr 2015
- Study completion10 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraception: Optional Applicator for Insertion of Vaginal RingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275546
- Sponsor's protocol ID
- 8342A-063
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2014
- Last updated
- 17 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27207028
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Randomized, Two-period Crossover Study on the Insertion of MK-8342A (NuvaRing®) Placebo With and Without the Use of NuvaRing Applicator in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT02275546
- Acronym / sponsor ID
- 8342A-063
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2014 (actual)
- Primary completion
- 10 Apr 2015 (actual)
- Study completion
- 10 Apr 2015 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Posted 28 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applicator→No Applicator (manual) | Experimental | Drug: Placebo vaginal ring, Device: Single-use, non-sterile applicatorTreatment period 1: Participants will use applicator to insert vaginal ring. Treatment period 2: Participants will manually insert vaginal ring using fingers only. |
| No applicator (manual)→Applicator | Experimental | Drug: Placebo vaginal ring, Device: Single-use, non-sterile applicatorTreatment period 1: Participants will manually insert vaginal ring using fingers only. Treatment period 2: Participants will use applicator to insert vaginal ring. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo vaginal ringAlso: NuvaRingDrug-free placebo vaginal ring | Drug | Applicator→No Applicator (manual), No applicator (manual)→Applicator |
| Single-use, non-sterile applicatorAlso: NuvaRing ApplicatorSingle-use, non-sterile, plastic applicator for insertion of vaginal ring. | Device | Applicator→No Applicator (manual), No applicator (manual)→Applicator |
Primary outcome
Percentage of Participants With Successful Ring Insertion
Time frame: Day 1 (immediately after vaginal 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.
Percentage of Participants With Vaginal Ring Expulsion Within 48 Hours of Insertion
Time frame: Up to 48 hours after vaginal ring insertion
Participants completed a Follow-Up Questionnaire in which they asked if they experienced vaginal ring expulsion. Their answers were recorded and evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27207028Feldman 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Single-use, non-sterile applicator in people with Contraception: Optional Applicator for Insertion of Vaginal Ring, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Successful Ring Insertion (time frame: Day 1 (immediately after vaginal ring insertion)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02275546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.