ContraceptionPhase 4NCT01490190

Study of the Use of a Contraceptive Vaginal Ring (NuvaRing) in Normal Daily Practice in Indian Women (P07733)

A Phase 4 study testing Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) 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 study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception
What is being tested?: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: No sites listed yet
Study dates: 26 Dec 2011to 5 Dec 2012
Phase: Phase 4
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 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Women at risk of pregnancy and seeking contraception

Who cannot join

Exclusion criteria based on approved prescribing information in India:
Presence or history of venous thrombosis, with or without pulmonary embolism.
Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or
transient ischemic attack).
Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
History of migraine with focal neurological symptoms.

Show all 16Show fewer

Diabetes mellitus with vascular involvement.
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors)
Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Presence or history of liver tumors (benign or malignant).
Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced.
Undiagnosed vaginal bleeding.
Known or suspected pregnancy.
Hypersensitivity to the active substances or to any of the excipients of NuvaRing.
Women who are breast feeding

About this study

Official title: Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women

This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.

Conditions: Contraception
Being tested: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

What participants receive

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

Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)Drug
Also called NuvaRing, SCH 900702
Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.

Study groups in NCT01490190
Study group	Role	What they receive
NuvaRing	Experimental	Not described Receives: Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

What is being measured

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

Number of Participants With Regular Menstrual Cycles
The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.
Measured: Up to 84 days (three 28-day cycles)
Average Number of Bleeding Days Per Cycle
Mean duration of menstruation, per day, per cycle, during the study period.
Measured: Up to 84 days (three 28-day cycles)
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.
Measured: Up to 84 days (three 28-day cycles)
Number of Participants With Intermenstrual Bleeding/Spotting
Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.
Measured: Up to 84 days (three 28-day cycles)
Number of Bleeding Days Per Cycle
Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.
Measured: Up to 84 days (three 28-day cycles)
Number of Spotting Days Per Cycle
Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.
Measured: Up to 84 days (three 28-day cycles)
Participants' Assessment of Ease of Insertion of Vaginal Ring
Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Participants' Assessment of Ease of Removal of Vaginal Ring
Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Participants' Assessment of Feeling Vaginal Ring at Any Time
Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Frequency of Partner Feeling Vaginal Ring During Intercourse
Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Frequency of Partner Objecting to Vaginal Ring Use
Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Participants' Overall Satisfaction With Vaginal Ring
Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.
Measured: Up to 84 days (three 28-day cycles)
Number of Participants Who Plan to Continue Using Vaginal Ring
Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.
Measured: Up to 84 days (three 28-day cycles)
Number of Participants Who Would Recommend Vaginal Ring to Others
Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.
Measured: Up to 84 days (three 28-day cycles)

Secondary outcomes (3)

Number of Pregnancies Due to Contraceptive Method Failure During the Study
For participants with suspected pregnancy during in-treatment period, pregnancy was to be confirmed by hCG qualitative analysis using strip and/or other test(s) at the discretion of the treating physician.
Measured: Up to 84 days (three 28-day cycles)
Number of Participants Who Reported at Least One Adverse Event During the Study
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic, or medical device, which does not necessarily have a causal relationship with the treatment.
Measured: Up to 84 days (three 28-day cycles)
Number of Participants Who Reported a Serious Adverse Event During the Study
A serious adverse event is any adverse drug or biologic or device experience that results in death, a life-threatening adverse event, persistent or significant disability or incapacity; requires in-patient hospitalization, or prolonged hospitalization; or causes a congenital anomaly or birth defect.
Measured: Up to 84 days (three 28-day cycles)

Timeline

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

26 Dec 20115 Dec 2012

First posted12 Dec 2011 (estimated)
Study start26 Dec 2011
Primary completion5 Dec 2012
Study completion5 Dec 2012

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.
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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01490190
Sponsor's protocol ID: P07733
Other IDs: CTRI/2011/11/002098
Status last verified: Feb 2022
First submitted: 22 Nov 2011
Last updated: 24 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contraceptive Vaginal Ring Releasing Etonogestrel and Ethinylestradiol (NuvaRing): Cycle Control, Acceptability and Tolerability Study in Indian Women
ClinicalTrials.gov ID: NCT01490190
Acronym / sponsor ID: P07733
Conditions: Contraception
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 26 Dec 2011 (actual)
Primary completion: 5 Dec 2012 (actual)
Study completion: 5 Dec 2012 (actual)
First posted: 12 Dec 2011 (estimated)
Results: Posted 14 Jan 2014

Clinical summary

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

This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NuvaRing	Experimental	Drug: Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Women at risk of pregnancy and seeking contraception

Key exclusion criteria (16 listed)

Presence or history of venous thrombosis, with or without pulmonary embolism.
Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or
transient ischemic attack).
Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
History of migraine with focal neurological symptoms.

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
Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)Also: NuvaRing, SCH 900702Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.	Drug	NuvaRing

Primary outcome

Number of Participants With Regular Menstrual Cycles
Time frame: Up to 84 days (three 28-day cycles)
The number of participants who experienced regular menstrual bleeding patterns throughout the period of NuvaRing use. Bleeding patterns were to be characterized by particpants as regular or irregular.
Average Number of Bleeding Days Per Cycle
Time frame: Up to 84 days (three 28-day cycles)
Mean duration of menstruation, per day, per cycle, during the study period.
Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring
Time frame: Up to 84 days (three 28-day cycles)
Intensity of menstruation, as indicated by the median number of pads used per day by participants during each cycle of NuvaRing use.
Number of Participants With Intermenstrual Bleeding/Spotting
Time frame: Up to 84 days (three 28-day cycles)
Number of participants who experienced vaginal bleeding, which includes BLEEDING or SPOTTING, at any time during a cycle other than normal menstruation while in the study. Vaginal bleeding that required >=2 pads per day was classified as BLEEDING. Vaginal bleeding that required <=1 pad per day was classified as SPOTTING.
Number of Bleeding Days Per Cycle
Time frame: Up to 84 days (three 28-day cycles)
Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING.
Number of Spotting Days Per Cycle
Time frame: Up to 84 days (three 28-day cycles)
Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING.
Participants' Assessment of Ease of Insertion of Vaginal Ring
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked to classify their ability to insert the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.
Participants' Assessment of Ease of Removal of Vaginal Ring
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked to classify their ability to remove the NuvaRing as very easy, easy, neutral, difficult, very difficult, or failed. The number of participants who responded to each category was reported.
Participants' Assessment of Feeling Vaginal Ring at Any Time
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked to assess whether they could feel the NuvaRing at any time and to characterize how often as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Participants' Assessment of Feeling Vaginal Ring During Intercourse
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked to assess whether they could feel the NuvaRing during intercourse and to characterize how often as one the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Frequency of Partner Feeling Vaginal Ring During Intercourse
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked if their partners could feel the NuvaRing during intercourse and to characterize their partners' experience as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Frequency of Partner Objecting to Vaginal Ring Use
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked if their partners objected to their using the NuvaRing during intercourse and to characterize the frequency of their partners' objections as one of the following: never, rarely, occasionally, mostly, or always. The number of participants who responded to each category was reported.
Participants' Overall Satisfaction With Vaginal Ring
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked to characterize their overall satisfaction with the NuvaRing as one of the following: very satisfied, satisfied, neutral, unsatisfied, or very unsatisfied. The number of participants who responded to each category was reported.
Number of Participants Who Plan to Continue Using Vaginal Ring
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked at follow-up visits after every cycle whether they planned to continue using NuvaRing, and their answers were recorded.
Number of Participants Who Would Recommend Vaginal Ring to Others
Time frame: Up to 84 days (three 28-day cycles)
Participants were asked at follow-up visits after every cycle whether they would recommend NuvaRing to other women, and their answers were reported.

3 secondary outcomes

Number of Pregnancies Due to Contraceptive Method Failure During the Study
Time frame: Up to 84 days (three 28-day cycles)
Number of Participants Who Reported at Least One Adverse Event During the Study
Time frame: Up to 84 days (three 28-day cycles)
Number of Participants Who Reported a Serious Adverse Event During the Study
Time frame: Up to 84 days (three 28-day cycles)

Results and safety

Results posted to the registry on 14 Jan 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
NuvaRing: Safety Population	252	204

Primary outcome: Number of Participants With Regular Menstrual Cycles

Time frame: Up to 84 days (three 28-day cycles). Number. Unit: Participants

Measure	NuvaRing n = 204
First cycle: Regular	192
First cycle: Irregular	9
First cycle: Missing data	3
Second cycle: Regular	199
Second cycle: Irregular	4
Second cycle: Missing data	1
Third cycle: Regular	200
Third cycle: Irregular	3

Population analysed: Per Protocol Population, which included all participants who completed the study as per protocol.

Primary outcome: Average Number of Bleeding Days Per Cycle

Time frame: Up to 84 days (three 28-day cycles). Mean (Standard Deviation). Unit: Days

Measure	NuvaRing n = 203
First cycle (N = 201)	3.8 (1.24)
Second cycle (N = 203)	3.7 (1.13)
Third cycle (N = 203)	3.6 (0.98)

Population analysed: Per Protocol Population, which included all participants who completed the study as per protocol. Of the total Per Protocol Population (N = 204), data for this outcome measure were missing for 3 partcipants in the first cycle, 1 participant in the second cycle, and 1 participant in the third cycle.

Primary outcome: Average Number of Pads Used Per Day, Per Cycle, During Menstruation While Using Ring

Time frame: Up to 84 days (three 28-day cycles). Median (Full Range). Unit: Pads

Measure	NuvaRing n = 203
First cycle (N = 201)	2 (0 to 6)
Second cycle (N = 203)	2 (1 to 10)
Third cycle (N = 203)	2 (1 to 7)

Primary outcome: Number of Participants With Intermenstrual Bleeding/Spotting

Time frame: Up to 84 days (three 28-day cycles). Number. Unit: Participants

Measure	NuvaRing n = 204
First cycle: Total bleeding/spotting	5
First cycle: Bleeding	1
First cycle: Spotting	4
Second cycle: Total bleeding/spotting	0
Second cycle: Bleeding	0
Second cycle: Spotting	0
Third cycle: Total bleeding/spotting	1
Third cycle: Bleeding	0

Population analysed: Per Protocol Population, which included all participants who completed the study as per protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 84 days (three 28-day cycles). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NuvaRing: Safety Population	0 of 252 (0%)	13 of 252 (5.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) 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 1 inclusion and 16 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 24 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 14 Jan 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?

Number of Participants With Regular Menstrual Cycles (time frame: Up to 84 days (three 28-day cycles)). The study lists 15 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 NCT01490190.

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 24 May 2024.