Trial · NCT00455156

Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring

NCT00455156, Phase 3, Completed, Premier Research; results first posted 2026-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring. Trials, record NCT00455156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00455156

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring
NCT number: NCT00455156
Status: Completed
Phases: Phase 3
Enrollment: 1,200 participants, actual
Lead sponsor: Premier Research
Conditions: Contraception
Interventions: 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR)
First posted: 2007-04-03
Last updated: 2026-01-23
Results first posted: 2026-01-23

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Contraceptive Efficacy Using the Pearl Index for All Subjects	12 Months	The Pearl Index derived from using all cycles for which back up contraception is not used will be the primary efficacy endpoint. The Pearl Index is used to indicate how many women out of 100 would get pregnant using a specific birth control method over a year. It uses the formula: (Pregnancies x 12 x 100) / (Women x Months of study). The lower the Pearl Index, the more effective the contraceptive.
Primary	Changes From Baseline in Pap Smear	Visit 0 and Visit 5, up to 13 months	Changes from Baseline in Pap Smear results as measured at Screening (Baseline) and at Visit 5 (Cycle 13)
Primary	Contraceptive Efficacy Using the Pearl Index for Subjects Less Than or Equal to 35 Years of Age	12 Months	The Pearl Index derived from using all cycles for which back up contraception is not used will be the primary efficacy endpoint and analyzed for subjects that are less than or equal to 35 years of age. The Pearl Index is used to indicate how many women out of 100 would get pregnant using a specific birth control method over a year. It uses the formula: (Pregnancies x 12 x 100) / (Women x Months of study). The lower the Pearl Index, the more effective the contraceptive.
Secondary	Bleeding Patterns Assessed by Number of Scheduled Bleeding Days	Cycles 1-13, up to 13 months	Scheduled bleeding is any bleeding or spotting that occurs during the CVR-free intervals, regardless of the duration of the regimen. The bleeding may continue into days 1-4 of the subsequent cycle. Bleeding days are assessed based on subject diaries completed during Cycles 1-13.
Secondary	Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days	Cycles 1-13, up to 13 months	Unscheduled bleeding or spotting is any bleeding or spotting that occurs while taking active hormones with 2 exceptions: 1) Bleeding/spotting that occurs during a CVR-free interval and continues to Days 1-4 of the next active cycle is not considered unscheduled and 2) Bleeding/spotting reported during Days 1-7 of the first cycle of study CVR insertion is not considered unscheduled. Bleeding days are assessed based on subject diaries completed during Cycles 1-13.
Secondary	Return to Fertility Assessed by Intended Pregnancies	Up to 6 Months	Women who state, during the course of the study, that they wish to discontinue to become pregnant and women who indicate, at the end of the study, that they plan to become pregnant as soon as possible will be followed for up to six months or until earlier pregnancy.
Secondary	Number of Participants With Return of Post-Treatment Menses Within 6 Months	Up to 6 Months	Women, who do not wish to become pregnant at the time of termination or end of treatment, will be followed until the time of their first post-treatment menses.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Contraceptive Efficacy Using the Pearl Index for All Subjects	12 Months	All cycles with documented backup contraception are excluded unless the subject became pregnant in that cycle. All cycles after conception for women who became pregnant are excluded.	Number of pregnancies per 100 women mths	NUMBER
PRIMARY	Changes From Baseline in Pap Smear	Visit 0 and Visit 5, up to 13 months	Subjects that were treated and had a pap smear performed at the respective timepoints were analyzed	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Contraceptive Efficacy Using the Pearl Index for Subjects Less Than or Equal to 35 Years of Age	12 Months	Only subjects less than or equal to 35 years of age are included in this analysis. All cycles with documented backup contraception are excluded unless the subject became pregnant in that cycle. All cycles after conception for women who became pregnant are excluded.	Number of pregnancies per 100 women mths	NUMBER
SECONDARY	Bleeding Patterns Assessed by Number of Scheduled Bleeding Days	Cycles 1-13, up to 13 months	subjects that completed diaries during the respective cycles are included.	Days	MEAN
SECONDARY	Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days	Cycles 1-13, up to 13 months	subjects that completed diaries during the respective cycles are included.	Days	MEAN
SECONDARY	Return to Fertility Assessed by Intended Pregnancies	Up to 6 Months	Women who state, during the course of the study, that they wish to discontinue to become pregnant and women who indicate, at the end of the study, that they plan to become pregnant as soon as possible will be followed for up to six months or until earlier pregnancy. Only subjects that wanted to become pregnant are included in this analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Return of Post-Treatment Menses Within 6 Months	Up to 6 Months	Women, who do not wish to become pregnant at the time of termination or end of treatment, will be followed until the time of their first post-treatment menses. Only subjects that did not want to become pregnant or use hormonal contraception are included in this analysis.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Contraceptive Efficacy Using the Pearl Index for All Subjects	150/15 NES/EE CVR		2.96	99% Confidence Interval 1.93 to 4.55	Number of pregnancies per 100 women mths
Changes From Baseline in Pap Smear	150/15 NES/EE CVR	Visit 0/Baseline: Normal Pap	1060		Participants
Changes From Baseline in Pap Smear	150/15 NES/EE CVR	Visit 0/Baseline: ASCUS HPV Negative Pap	47		Participants
Changes From Baseline in Pap Smear	150/15 NES/EE CVR	Visit 0/Baseline: Abnormal, Other Pap	32		Participants
Changes From Baseline in Pap Smear	150/15 NES/EE CVR	Visit 5/Cycle 13: Normal Pap	629		Participants
Changes From Baseline in Pap Smear	150/15 NES/EE CVR	Visit 5/Cycle 13: ASCUS HPV Negative Pap	48		Participants
Changes From Baseline in Pap Smear	150/15 NES/EE CVR	Visit 5/Cycle 13: Abnormal, Other Pap	67		Participants
Contraceptive Efficacy Using the Pearl Index for Subjects Less Than or Equal to 35 Years of Age	150/15 NES/EE CVR		3.92	99% Confidence Interval 2.60 to 5.89	Number of pregnancies per 100 women mths
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days	150/15 NES/EE CVR	Cycle 1	4.3	Standard Deviation 1.75	Days
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days	150/15 NES/EE CVR	Cycle 2	4.6	Standard Deviation 2.04	Days

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	150/15 NES/EE CVR	1,143
Overall Study	COMPLETED	150/15 NES/EE CVR	585
Overall Study	NOT COMPLETED	150/15 NES/EE CVR	558

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	NASOPHARYNGITIS	Infections and infestations	150/15 NES/EE CVR	212	1,143	212
other	UPPER RESPIRATORY TRACK INFECTION	Infections and infestations	150/15 NES/EE CVR	204	1,143	204
other	VULVOVAGINAL MYCOTIC INFECTION	Infections and infestations	150/15 NES/EE CVR	142	1,143	142
other	URINARY TRACT INFECTION	Infections and infestations	150/15 NES/EE CVR	97	1,143	97
other	INFLUENZA	Infections and infestations	150/15 NES/EE CVR	98	1,143	98
other	SINUSITIS	Infections and infestations	150/15 NES/EE CVR	71	1,143	71
other	VAGINAL DISCHARGE	Reproductive system and breast disorders	150/15 NES/EE CVR	75	1,143	75
other	METTRORRHAGIA	Reproductive system and breast disorders	150/15 NES/EE CVR	58	1,143	58
other	BREAST TENDERNESS	Respiratory, thoracic and mediastinal disorders	150/15 NES/EE CVR	69	1,143	69
other	GENITAL PRURITUS FEMALE	Reproductive system and breast disorders	150/15 NES/EE CVR	60	1,143	60

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	150/15 NES/EE CVR	0	1,143
Total, other adverse events	150/15 NES/EE CVR	1,007	1,143
Total, serious adverse events	150/15 NES/EE CVR	21	1,143

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26267119	DERIVED	PubMed
31231065	DERIVED	PubMed
31398307	DERIVED	PubMed
38295968	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00455156

GET https://conductscience.org/api/trials/v1/NCT00455156/results?page=2

API reference For AI assistants