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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490190

Enrollment

252

Registered

2011-12-12

Start date

2011-12-26

Completion date

2012-12-05

Last updated

2024-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Brief 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.

Interventions

DRUGEthinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Women at risk of pregnancy and seeking contraception

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Would Recommend Vaginal Ring to Others	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.
Frequency of Partner Objecting to Vaginal Ring Use	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	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	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 With Regular Menstrual Cycles	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	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	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	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	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	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	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	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	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	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	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.

Secondary

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

Participant flow

Participants by arm

Arm	Count
NuvaRing: Safety Population Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.	252
Total	252

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	17
Overall Study	Inconvenience	1
Overall Study	Lost to Follow-up	13
Overall Study	Protocol Violation	5
Overall Study	Relocation	1
Overall Study	Ring expulsion	2
Overall Study	Withdrawal by Subject	9

Baseline characteristics

Characteristic	NuvaRing: Safety Population
Age, Continuous	29.5 Years STANDARD_DEVIATION 5.32
Sex: Female, Male Female	252 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	13 / 252
serious Total, serious adverse events	0 / 252