Trial Outcomes & Findings for Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring (NCT NCT00455156)
NCT ID: NCT00455156
Last Updated: 2026-01-23
Results Overview
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.
COMPLETED
PHASE3
1200 participants
12 Months
2026-01-23
Participant Flow
Participant milestones
| Measure |
150/15 NES/EE CVR
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
|
|---|---|
|
Overall Study
STARTED
|
1143
|
|
Overall Study
COMPLETED
|
585
|
|
Overall Study
NOT COMPLETED
|
558
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety, Efficacy and Cycle Control of a Contraceptive Vaginal Ring
Baseline characteristics by cohort
| Measure |
150/15 NES/EE CVR
n=1143 Participants
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1143 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=270 Participants
|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 5.01 • n=270 Participants
|
|
Sex: Female, Male
Female
|
1143 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=270 Participants
|
|
Region of Enrollment
United States
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1143 participants
n=270 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
150/15 NES/EE CVR
n=9212 Cycles
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
|
|---|---|
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Contraceptive Efficacy Using the Pearl Index for All Subjects
|
2.96 Number of pregnancies per 100 women mths
Interval 1.93 to 4.55
|
PRIMARY outcome
Timeframe: Visit 0 and Visit 5, up to 13 monthsPopulation: Subjects that were treated and had a pap smear performed at the respective timepoints were analyzed
Changes from Baseline in Pap Smear results as measured at Screening (Baseline) and at Visit 5 (Cycle 13)
Outcome measures
| Measure |
150/15 NES/EE CVR
n=1139 Participants
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
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|---|---|
|
Changes From Baseline in Pap Smear
Visit 0/Baseline: Normal Pap
|
1060 Participants
|
|
Changes From Baseline in Pap Smear
Visit 0/Baseline: ASCUS HPV Negative Pap
|
47 Participants
|
|
Changes From Baseline in Pap Smear
Visit 0/Baseline: Abnormal, Other Pap
|
32 Participants
|
|
Changes From Baseline in Pap Smear
Visit 5/Cycle 13: Normal Pap
|
629 Participants
|
|
Changes From Baseline in Pap Smear
Visit 5/Cycle 13: ASCUS HPV Negative Pap
|
48 Participants
|
|
Changes From Baseline in Pap Smear
Visit 5/Cycle 13: Abnormal, Other Pap
|
67 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
150/15 NES/EE CVR
n=7636 Cycles
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
|
|---|---|
|
Contraceptive Efficacy Using the Pearl Index for Subjects Less Than or Equal to 35 Years of Age
|
3.92 Number of pregnancies per 100 women mths
Interval 2.6 to 5.89
|
SECONDARY outcome
Timeframe: Cycles 1-13, up to 13 monthsPopulation: subjects that completed diaries during the respective cycles are included.
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.
Outcome measures
| Measure |
150/15 NES/EE CVR
n=1143 Participants
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
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|---|---|
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Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 12
|
4.4 Days
Standard Deviation 1.97
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 13
|
4.1 Days
Standard Deviation 2.20
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 1
|
4.3 Days
Standard Deviation 1.75
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 2
|
4.6 Days
Standard Deviation 2.04
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 3
|
4.5 Days
Standard Deviation 2.02
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 4
|
4.5 Days
Standard Deviation 2.00
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 5
|
4.4 Days
Standard Deviation 2.05
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 6
|
4.4 Days
Standard Deviation 2.07
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 7
|
4.4 Days
Standard Deviation 1.96
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 8
|
4.3 Days
Standard Deviation 2.01
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 9
|
4.4 Days
Standard Deviation 2.01
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 10
|
4.4 Days
Standard Deviation 2.04
|
|
Bleeding Patterns Assessed by Number of Scheduled Bleeding Days
Cycle 11
|
4.5 Days
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Cycles 1-13, up to 13 monthsPopulation: subjects that completed diaries during the respective cycles are included.
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.
Outcome measures
| Measure |
150/15 NES/EE CVR
n=1143 Participants
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
|
|---|---|
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Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 13
|
1.1 Days
Standard Deviation 2.53
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 1
|
1.3 Days
Standard Deviation 2.91
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 2
|
0.8 Days
Standard Deviation 2.33
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 3
|
0.7 Days
Standard Deviation 2.05
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 4
|
0.8 Days
Standard Deviation 2.24
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 5
|
0.8 Days
Standard Deviation 2.05
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 6
|
0.8 Days
Standard Deviation 2.05
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 7
|
1.0 Days
Standard Deviation 2.42
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 8
|
0.9 Days
Standard Deviation 2.16
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 9
|
1.0 Days
Standard Deviation 2.20
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|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 10
|
1.0 Days
Standard Deviation 2.35
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 11
|
1.1 Days
Standard Deviation 2.59
|
|
Bleeding Patterns Assessed by Number of Unscheduled Bleeding Days
Cycle 12
|
1.1 Days
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Up to 6 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
150/15 NES/EE CVR
n=18 Participants
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
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|---|---|
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Return to Fertility Assessed by Intended Pregnancies
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 6 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
150/15 NES/EE CVR
n=145 Participants
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
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|---|---|
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Number of Participants With Return of Post-Treatment Menses Within 6 Months
|
138 Participants
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Adverse Events
150/15 NES/EE CVR
Serious adverse events
| Measure |
150/15 NES/EE CVR
n=1143 participants at risk
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
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|---|---|
|
Infections and infestations
PNEUMONIA
|
0.17%
2/1143 • Number of events 2 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
PYELONEPHRITIS
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.17%
2/1143 • Number of events 2 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
NAUSEA
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
VOMITING
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Immune system disorders
FOOD ALLERGY
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SALIVARY GLAND ADENOMA
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Nervous system disorders
HEADACHE
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.17%
2/1143 • Number of events 2 • Enrollment through follow-up, up to 18 months
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Ear and labyrinth disorders
VERTIGO
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
General disorders
INFUSION SITE PHLEBITIS
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Reproductive system and breast disorders
UTERINE SPASM
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
|
Social circumstances
DRUG ABUSER
|
0.09%
1/1143 • Number of events 1 • Enrollment through follow-up, up to 18 months
|
Other adverse events
| Measure |
150/15 NES/EE CVR
n=1143 participants at risk
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR): 150 mg of Nestorone and 15 mg of ethinyl estradiol (150/15 NES/EE CVR), administered via vaginal ring, used on a 21/7 days in/out schedule for no more than one year.
|
|---|---|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
6.6%
75/1143 • Number of events 75 • Enrollment through follow-up, up to 18 months
|
|
Reproductive system and breast disorders
METTRORRHAGIA
|
5.1%
58/1143 • Number of events 58 • Enrollment through follow-up, up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
BREAST TENDERNESS
|
6.0%
69/1143 • Number of events 69 • Enrollment through follow-up, up to 18 months
|
|
Reproductive system and breast disorders
GENITAL PRURITUS FEMALE
|
5.2%
60/1143 • Number of events 60 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
NAUSEA
|
21.3%
244/1143 • Number of events 244 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
VOMITING
|
10.2%
117/1143 • Number of events 117 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
10.5%
120/1143 • Number of events 120 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
8.0%
92/1143 • Number of events 92 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.7%
65/1143 • Number of events 65 • Enrollment through follow-up, up to 18 months
|
|
Gastrointestinal disorders
STOMACH DISCOMFORT
|
5.2%
59/1143 • Number of events 59 • Enrollment through follow-up, up to 18 months
|
|
Nervous system disorders
HEADACHE
|
43.4%
496/1143 • Number of events 496 • Enrollment through follow-up, up to 18 months
|
|
Nervous system disorders
MIGRAINE
|
5.1%
58/1143 • Number of events 58 • Enrollment through follow-up, up to 18 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
10.0%
114/1143 • Number of events 114 • Enrollment through follow-up, up to 18 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
7.2%
82/1143 • Number of events 82 • Enrollment through follow-up, up to 18 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
4.9%
56/1143 • Number of events 56 • Enrollment through follow-up, up to 18 months
|
|
Psychiatric disorders
INSOMNIA
|
6.3%
72/1143 • Number of events 72 • Enrollment through follow-up, up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
8.3%
95/1143 • Number of events 95 • Enrollment through follow-up, up to 18 months
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.9%
67/1143 • Number of events 67 • Enrollment through follow-up, up to 18 months
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
12.6%
144/1143 • Number of events 144 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
SINUSITIS
|
6.2%
71/1143 • Number of events 71 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.5%
97/1143 • Number of events 97 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
INFLUENZA
|
8.6%
98/1143 • Number of events 98 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
12.4%
142/1143 • Number of events 142 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
NASOPHARYNGITIS
|
18.5%
212/1143 • Number of events 212 • Enrollment through follow-up, up to 18 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACK INFECTION
|
17.8%
204/1143 • Number of events 204 • Enrollment through follow-up, up to 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place