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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2011/11/002098 | Registry Identifier | CTRI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuvaRing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 84 days (three 28-day cycles) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria based on approved prescribing information in India:
transient ischemic attack).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age data were only available for 218 participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
Up to 84 days (three 28-day cycles)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA Version 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| C516519 | NuvaRing |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
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|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. |
| 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. | Up to 84 days (three 28-day cycles) |
| Lost to Follow-up |
|
| Relocation |
|
| Inconvenience |
|
| Ring expulsion |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Average Number of Bleeding Days Per Cycle | Mean duration of menstruation, per day, per cycle, during the study period. | 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. | Posted | Mean | Standard Deviation | Days | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | 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. | Posted | Median | Full Range | Pads | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | Number of Bleeding Days Per Cycle | Intermenstrual vaginal bleeding that required >=2 pads per day was classified as BLEEDING. | One participant in Per Protocol Population who experienced vaginal bleeding was evaluated for duration of bleeding. | Posted | Mean | Standard Deviation | Days | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | Number of Spotting Days Per Cycle | Intermenstrual vaginal bleeding that required <=1 pad per day was classified as SPOTTING. | Participants in the Per Protocol Population who experienced spotting were evaluated for duration of spotting. | Posted | Mean | Standard Deviation | Days | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Per Protocol Population, which included all participants who completed the study as per protocol. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Primary | 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. | Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Secondary | 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. | Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period. | Posted | Number | Pregnancies | Up to 84 days (three 28-day cycles) |
|
|
|
| Secondary | 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. | Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| Secondary | 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. | Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period. | Posted | Number | Participants | Up to 84 days (three 28-day cycles) |
|
|
|
| 0 |
| 252 |
| 13 |
| 252 |
The principal investigator agrees not to publish or publicly present interim results of the Study without prior written consent of sponsor, agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation, and permits sponsor to review copies of abstracts and manuscripts for publication, and slides and text of oral presentations and text of any electronically transmitted media such as the Internet, World Wide Web, etc.
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Second cycle: Total bleeding/spotting |
|
| Second cycle: Bleeding |
|
| Second cycle: Spotting |
|
| Third cycle: Total bleeding/spotting |
|
| Third cycle: Bleeding |
|
| Third cycle: Spotting |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| First cycle: Difficult |
|
| First cycle: Very difficult |
|
| First cycle: Failed |
|
| Second cycle: Very easy |
|
| Second cycle: Easy |
|
| Second cycle: Neutral |
|
| Second cycle: Difficult |
|
| Second cycle: Very difficult |
|
| Second cycle: Failed |
|
| Third cycle: Very easy |
|
| Third cycle: Easy |
|
| Third cycle: Neutral |
|
| Third cycle: Difficult |
|
| Third cycle: Very difficult |
|
| Third cycle: Failed |
|
| Title | Measurements |
|---|---|
|
| First cycle: Difficult |
|
| First cycle: Very difficult |
|
| First cycle: Failed |
|
| Second cycle: Very easy |
|
| Second cycle: Easy |
|
| Second cycle: Neutral |
|
| Second cycle: Difficult |
|
| Second cycle: Very difficult |
|
| Second cycle: Failed |
|
| Third cycle: Very easy |
|
| Third cycle: Easy |
|
| Third cycle: Neutral |
|
| Third cycle: Difficult |
|
| Third cycle: Very different |
|
| Third cycle: Failed |
|
| Title | Measurements |
|---|---|
|
| First cycle: Mostly |
|
| First cycle: Always |
|
| Second cycle: Never |
|
| Second cycle: Rarely |
|
| Second cycle: Occasionally |
|
| Second cycle: Mostly |
|
| Second cycle: Always |
|
| Third cycle: Never |
|
| Third cycle: Rarely |
|
| Third cycle: Occasionally |
|
| Third cycle: Mostly |
|
| Third cycle: Always |
|
| Title | Measurements |
|---|---|
|
| First cycle: Mostly |
|
| First cycle: Always |
|
| Second cycle: Never |
|
| Second cycle: Rarely |
|
| Second cycle: Occasionally |
|
| Second cycle: Mostly |
|
| Second cycle: Always |
|
| Third cycle: Never |
|
| Third cycle: Rarely |
|
| Third cycle: Occasionally |
|
| Third cycle: Mostly |
|
| Third cycle: Always |
|
| Title | Measurements |
|---|---|
|
| First cycle: Mostly |
|
| First cycle: Always |
|
| Second cycle: Never |
|
| Second cycle: Rarely |
|
| Second cycle: Occasionally |
|
| Second cycle: Mostly |
|
| Second cycle: Always |
|
| Third cycle: Never |
|
| Third cycle: Rarely |
|
| Third cycle: Occasionally |
|
| Third cycle: Mostly |
|
| Third cycle: Always |
|
| Title | Measurements |
|---|---|
|
| First cycle: Mostly |
|
| First cycle: Always |
|
| Second cycle: Never |
|
| Second cycle: Rarely |
|
| Second cycle: Occasionally |
|
| Second cycle: Mostly |
|
| Second cycle: Always |
|
| Third cycle: Never |
|
| Third cycle: Rarely |
|
| Third cycle: Occasionally |
|
| Third cycle: Mostly |
|
| Third cycle: Always |
|
| Title | Measurements |
|---|---|
|
| First cycle (N = 252): Unsatisfied |
|
| First cycle (N = 252): Very unsatisfied |
|
| First cycle (N = 252): Missing data |
|
| Second cycle (N = 213): Very satisfied |
|
| Second cycle (N = 213): Satisfied |
|
| Second cycle(N = 213): Neutral |
|
| Second cycle (N = 213): Unsatisfied |
|
| Second cycle (N = 213): Very unsatisfied |
|
| Second cycle (N = 213): Missing data |
|
| Third cycle (N = 207): Very satisfied |
|
| Third cycle (N = 207): Satisfied |
|
| Third cycle (N = 207): Neutral |
|
| Third cycle (N = 207): Unsatisfied |
|
| Third cycle (N = 207): Very unsatisfied |
|
| Third cycle (N = 207): Missing data |
|
| Title | Measurements |
|---|---|
|
| Second cycle (N = 213): Yes |
|
| Second cycle (N = 213): No |
|
| Second cycle (N = 213): Missing data |
|
| Third cycle (N = 207): Yes |
|
| Third cycle (N = 207): No |
|
| Third cycle (N = 207): Missing data |
|
| Title | Measurements |
|---|---|
|
| Second cycle (N = 213): Yes |
|
| Second cycle (N = 213): No |
|
| Second cycle (N = 213): Missing data |
|
| Third cycle (N = 207): Yes |
|
| Third cycle (N = 207): No |
|
| Third cycle (N = 207): Missing data |
|
| Title | Measurements |
|---|---|
|
| Second cycle (N = 213): Yes |
|
| Second cycle (N = 213): No |
|
| Second cycle (N = 213): Missing data |
|
| Third cycle (N = 207): Yes |
|
| Third cycle (N = 207): No |
|
| Third cycle (N = 207): Missing data |
|