ContraceptionPhase 3NCT01277211

A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)

A Phase 3 study testing ENG 120 µg + EE 15 µg intravaginal ring and DRSP 3 mg + EE 30 µg in people with Contraception, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: ENG 120 µg + EE 15 µg intravaginal ring and DRSP 3 mg + EE 30 µg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 983 participants
Where: No sites listed yet
Study dates: 19 Sep 2011to 18 Sep 2013
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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
Body mass index ≥18 and ≤29 kg/m^2

Who cannot join

Contraindications for contraceptive steroids
Abnormal cervical smear corresponding to indeterminate changes at screening
Clinically relevant abnormal laboratory result at screening as judged by the investigator.

About this study

Official title: A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women

Read the detailed description

The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.

Conditions: Contraception
Being tested: ENG 120 µg + EE 15 µg intravaginal ring, DRSP 3 mg + EE 30 µg
Keywords: Contraception, NuvaRing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ENG 120 µg + EE 15 µg intravaginal ringDrug
Also called NuvaRing
13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.
DRSP 3 mg + EE 30 µgDrug
Also called Yasmin
13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.

Study groups in NCT01277211
Study group	Role	What they receive
ENG-EE (NuvaRing)	Experimental	Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE. Receives: Drug: ENG 120 µg + EE 15 µg intravaginal ring
DRSP-EE	Active comparator	Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE. Receives: Drug: DRSP 3 mg + EE 30 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

Pearl Index, by Treatment Group
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).
Measured: Up to 1 year

Secondary outcomes (2)

Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether they experienced vaginal bleeding, which included BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. (This is also known as "breakthough" bleeding.) Vaginal bleeding that required >=2 pads/tampons per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad/tampon per day was classified as SPOTTING.
Measured: Up to 1 year
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Participants kept diaries to record vaginal bleeding events. They were asked to record, on a daily basis, whether vaginal bleeding was present. Absence of withdrawal bleeding was defined as no bleeding/spotting during the expected bleeding period.
Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 201118 Sep 2013

First posted14 Jan 2011 (estimated)
Study start19 Sep 2011
Primary completion18 Sep 2013
Study completion18 Sep 2013

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 ContraceptionStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 983 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01277211
Sponsor's protocol ID: P06450
Status last verified: Feb 2022
First submitted: 12 Jan 2011
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Fan GS, Ren M, Di W, Su P, Chang Q, Wu S, Qin Y, Korver T, Marintcheva-Petrova M, Yacik C, McCrary Sisk C, Wang G. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):303-9. doi: 10.1080/13625187.2016.1186269. Epub 2016 Jun 24.
PubMed 27339759

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Controlled, Multi-Center Trial to Evaluate the Contraceptive Efficacy, Cycle Control, Safety and Acceptability of NuvaRing® (SCH 900702) in Chinese Women
ClinicalTrials.gov ID: NCT01277211
Acronym / sponsor ID: P06450
Conditions: Contraception
Keywords: Contraception, NuvaRing
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 983 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 19 Sep 2011 (actual)
Primary completion: 18 Sep 2013 (actual)
Study completion: 18 Sep 2013 (actual)
First posted: 14 Jan 2011 (estimated)
Results: Posted 15 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ENG-EE (NuvaRing)	Experimental	Drug: ENG 120 µg + EE 15 µg intravaginal ringParticipants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
DRSP-EE	Active comparator	Drug: DRSP 3 mg + EE 30 µgParticipants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
Body mass index ≥18 and ≤29 kg/m^2

Key exclusion criteria (3 listed)

Contraindications for contraceptive steroids
Abnormal cervical smear corresponding to indeterminate changes at screening
Clinically relevant abnormal laboratory result at screening as judged by the investigator.

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
ENG 120 µg + EE 15 µg intravaginal ringAlso: NuvaRing13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.	Drug	ENG-EE (NuvaRing)
DRSP 3 mg + EE 30 µgAlso: Yasmin13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.	Drug	DRSP-EE

Primary outcome

Pearl Index, by Treatment Group
Time frame: Up to 1 year
Primary Efficacy Outcome measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days).

2 secondary outcomes

Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle
Time frame: Up to 1 year
Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle
Time frame: Up to 1 year

Results and safety

Results posted to the registry on 15 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ENG-EE (NuvaRing)	738	588
DRSP-EE	245	182

Primary outcome: Pearl Index, by Treatment Group

Time frame: Up to 1 year. Mean (95% Confidence Interval). Unit: Pregnancies per 100 woman-years

Measure	ENG-EE (NuvaRing) n = 662	DRSP-EE n = 216
Value	1.92 (0.92 to 3.53)	3.12 (1.01 to 7.29)

ENG-EE (NuvaRing) vs DRSP-EE: Ratio of Pearl Indices: 0.61 (95% CI 0.19 to 2.29), p = 0.531, Poisson distribution method

Population analysed: Restricted Intent-to-Treat (R-ITT) Group, which consisted of all participants from the Intent-to-Treat (ITT) Group who had at least one cycle at risk (no condom use and confirmed intercourse).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ENG-EE (NuvaRing)	2 of 714 (0.3%)	0 of 714 (0%)	Not reported
DRSP-EE	4 of 232 (1.7%)	0 of 232 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27339759Fan GS, Ren M, Di W, Su P, Chang Q, Wu S, Qin Y, Korver T, Marintcheva-Petrova M, Yacik C, McCrary Sisk C, Wang G. Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):303-9. doi: 10.1080/13625187.2016.1186269. Epub 2016 Jun 24.
Individual participant dataSharing planned: No

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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 ENG 120 µg + EE 15 µg intravaginal ring and DRSP 3 mg + EE 30 µg in people with Contraception, 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 3 inclusion and 3 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 20 Jun 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 15 Sep 2014). 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?

Pearl Index, by Treatment Group (time frame: Up to 1 year). 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 NCT01277211, 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 20 Jun 2024.