Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy (NCT NCT01178125)
NCT ID: NCT01178125
Last Updated: 2021-11-09
Results Overview
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2858 participants
Primary outcome timeframe
thirteen 28-day cycles
Results posted on
2021-11-09
Participant Flow
A total of 3691 women desiring pregnancy prevention were screened for enrollment into this study. Of the 3691 subjects screened, 2858 subjects at 53 centers in the US and 9 centers in Israel met entry criteria and were considered to be eligible for enrollment into the study.
Of the 2858 enrolled, 93 participants withdrew from study before taking any investigational product, for the following reasons: lost to follow-up (n=34), consent withdrawn (n=17), sponsor request (n=13), withdrawn due to pregnancy (n=11), noncompliance (n=6), other (n=6), protocol violation (n=3), adverse event(n=2), investigator request (n=2).
Participant milestones
| Measure |
DR-102
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
|---|---|
|
Overall Study
STARTED
|
2858
|
|
Overall Study
Safety Population
|
2765
|
|
Overall Study
Intent to Treat (ITT) Population
|
2607
|
|
Overall Study
Pregnancy ITT (PITT) Population
|
2401
|
|
Overall Study
COMPLETED
|
1680
|
|
Overall Study
NOT COMPLETED
|
1178
|
Reasons for withdrawal
| Measure |
DR-102
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
|---|---|
|
Overall Study
Lost to Follow-up
|
397
|
|
Overall Study
Adverse Event
|
244
|
|
Overall Study
Withdrawal by Subject
|
209
|
|
Overall Study
Noncompliance
|
184
|
|
Overall Study
Pregnancy
|
55
|
|
Overall Study
Other Reason
|
39
|
|
Overall Study
Sponsor Decision
|
28
|
|
Overall Study
Protocol Violation
|
17
|
|
Overall Study
Investigator Decision
|
5
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of DR-102 for the Prevention of Pregnancy
Baseline characteristics by cohort
| Measure |
DR-102
n=2765 Participants
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 5.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2765 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1798 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
428 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
393 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
74 participants
n=5 Participants
|
|
Weight
|
72.4 kg
STANDARD_DEVIATION 18.62 • n=5 Participants
|
|
Body Mass Index (BMI)
|
26.9 kg/m^2
STANDARD_DEVIATION 6.54 • n=5 Participants
|
PRIMARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination desogestrel/ethinyl estradiol (DSG/EE) or ethinyl estradiol (EE) treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Outcome measures
| Measure |
DR-102: Total
n=24631 Treatment Cycles
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
n=21050 Treatment Cycles
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
n=3581 Treatment Cycles
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
All Users Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
|
2.43 pregnancies / 100 woman years exposure
Interval 1.778 to 3.237
|
2.35 pregnancies / 100 woman years exposure
Interval 1.661 to 3.22
|
2.90 pregnancies / 100 woman years exposure
Interval 1.254 to 5.716
|
PRIMARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Outcome measures
| Measure |
DR-102: Total
n=22309 Treatment Cycles
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
n=19086 Treatment Cycles
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
n=3223 Treatment Cycles
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Typical-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
|
2.68 pregnancies / 100 woman years exposure
Interval 1.963 to 3.574
|
2.59 pregnancies / 100 woman years exposure
Interval 1.832 to 3.551
|
3.23 pregnancies / 100 woman years exposure
Interval 1.394 to 6.35
|
PRIMARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used, and who were deemed to be compliant, per protocol.
Contraceptive failure is measured by the pregnancy rate calculated using the Pearl Index (PI) and the 7-day rule (a standardized process for calculating pregnancy rates). PI used all pregnancies, as determined by a positive urine and/or serum pregnancy test, except those for which the date of conception was before starting DR-102 or \> 7 days after stopping the combination DSG/EE or EE treatment of DR-102.The PI is defined as number of contraceptive failures per 100 women-years of exposure: (100)\*(total number of pregnancies)\*(13)/(total number of 28-day cycles). Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Outcome measures
| Measure |
DR-102: Total
n=22085 Treatment Cycles
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
n=18886 Treatment Cycles
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
n=3199 Treatment Cycles
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Compliant-Use Pregnancy Rates Based on Pearl Index (PI) Analyses for 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight, Using the 7-Day Rule
|
2.00 pregnancies / 100 woman years exposure
Interval 1.386 to 2.796
|
1.79 pregnancies / 100 woman years exposure
Interval 1.169 to 2.621
|
3.25 pregnancies / 100 woman years exposure
Interval 1.404 to 6.398
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle.
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles.
Outcome measures
| Measure |
DR-102: Total
n=2401 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
n=2034 Participants
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
n=367 Participants
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 13
|
0.0247 pregnancies / cumulative exposure
Interval 0.0185 to 0.0329
|
0.0240 pregnancies / cumulative exposure
Interval 0.0175 to 0.0329
|
0.0287 pregnancies / cumulative exposure
Interval 0.0143 to 0.057
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 1
|
0.0004 pregnancies / cumulative exposure
Interval 0.0001 to 0.003
|
0.0005 pregnancies / cumulative exposure
Interval 0.0001 to 0.0035
|
0 pregnancies / cumulative exposure
Interval 0.0 to 0.0
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 2
|
0.0013 pregnancies / cumulative exposure
Interval 0.0004 to 0.0039
|
0.0010 pregnancies / cumulative exposure
Interval 0.0002 to 0.004
|
0.0028 pregnancies / cumulative exposure
Interval 0.0004 to 0.0198
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 3
|
0.0031 pregnancies / cumulative exposure
Interval 0.0015 to 0.0064
|
0.0031 pregnancies / cumulative exposure
Interval 0.0014 to 0.0069
|
0.0028 pregnancies / cumulative exposure
Interval 0.0004 to 0.0198
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 4
|
0.0073 pregnancies / cumulative exposure
Interval 0.0045 to 0.0119
|
0.0070 pregnancies / cumulative exposure
Interval 0.0041 to 0.012
|
0.0091 pregnancies / cumulative exposure
Interval 0.0029 to 0.028
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 5
|
0.0078 pregnancies / cumulative exposure
Interval 0.0049 to 0.0125
|
0.0070 pregnancies / cumulative exposure
Interval 0.0041 to 0.012
|
0.0125 pregnancies / cumulative exposure
Interval 0.0047 to 0.033
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 6
|
0.0088 pregnancies / cumulative exposure
Interval 0.0056 to 0.0138
|
0.0082 pregnancies / cumulative exposure
Interval 0.0049 to 0.0136
|
0.0125 pregnancies / cumulative exposure
Interval 0.0047 to 0.033
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 7
|
0.0104 pregnancies / cumulative exposure
Interval 0.0069 to 0.0158
|
0.0094 pregnancies / cumulative exposure
Interval 0.0059 to 0.0151
|
0.0163 pregnancies / cumulative exposure
Interval 0.0068 to 0.0388
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 8
|
0.0132 pregnancies / cumulative exposure
Interval 0.0091 to 0.0192
|
0.0120 pregnancies / cumulative exposure
Interval 0.0078 to 0.0184
|
0.0202 pregnancies / cumulative exposure
Interval 0.0091 to 0.0446
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 9
|
0.0161 pregnancies / cumulative exposure
Interval 0.0114 to 0.0227
|
0.0153 pregnancies / cumulative exposure
Interval 0.0105 to 0.0225
|
0.0202 pregnancies / cumulative exposure
Interval 0.0091 to 0.0446
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 10
|
0.0184 pregnancies / cumulative exposure
Interval 0.0133 to 0.0255
|
0.0174 pregnancies / cumulative exposure
Interval 0.0121 to 0.025
|
0.0243 pregnancies / cumulative exposure
Interval 0.0116 to 0.0507
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 11
|
0.0190 pregnancies / cumulative exposure
Interval 0.0138 to 0.0262
|
0.0181 pregnancies / cumulative exposure
Interval 0.0127 to 0.0258
|
0.0243 pregnancies / cumulative exposure
Interval 0.0116 to 0.0507
|
|
All Users Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 12
|
0.0209 pregnancies / cumulative exposure
Interval 0.0153 to 0.0284
|
0.0195 pregnancies / cumulative exposure
Interval 0.0138 to 0.0276
|
0.0287 pregnancies / cumulative exposure
Interval 0.0143 to 0.057
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Compliant-use' set included PITT participants who completed at least one 28-day cycle and in which no other BCMs, including condoms, were used, and who were deemed to be compliant, per protocol.
A life table approach was used to estimate the cumulative pregnancy rate on a cycle-by-cycle basis for each of the thirteen 28-day treatment cycles. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Outcome measures
| Measure |
DR-102: Total
n=2317 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
n=1961 Participants
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
n=356 Participants
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 1
|
0 pregnancies / cumulative exposure
Interval 0.0 to 0.0
|
0 pregnancies / cumulative exposure
Interval 0.0 to 0.0
|
0 pregnancies / cumulative exposure
Interval 0.0 to 0.0
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 2
|
0.0015 pregnancies / cumulative exposure
Interval 0.0004 to 0.0059
|
0.0009 pregnancies / cumulative exposure
Interval 0.0001 to 0.0062
|
0.0047 pregnancies / cumulative exposure
Interval 0.0007 to 0.033
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 3
|
0.0038 pregnancies / cumulative exposure
Interval 0.0016 to 0.0092
|
0.0037 pregnancies / cumulative exposure
Interval 0.0014 to 0.0098
|
0.0047 pregnancies / cumulative exposure
Interval 0.0007 to 0.033
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 4
|
0.0063 pregnancies / cumulative exposure
Interval 0.0032 to 0.0126
|
0.0046 pregnancies / cumulative exposure
Interval 0.0019 to 0.0111
|
0.0154 pregnancies / cumulative exposure
Interval 0.005 to 0.0472
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 5
|
0.0063 pregnancies / cumulative exposure
Interval 0.0032 to 0.0126
|
0.0046 pregnancies / cumulative exposure
Interval 0.0019 to 0.0111
|
0.0154 pregnancies / cumulative exposure
Interval 0.005 to 0.0472
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 6
|
0.0063 pregnancies / cumulative exposure
Interval 0.0032 to 0.0126
|
0.0046 pregnancies / cumulative exposure
Interval 0.0019 to 0.0111
|
0.0154 pregnancies / cumulative exposure
Interval 0.005 to 0.0472
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 7
|
0.0072 pregnancies / cumulative exposure
Interval 0.0038 to 0.0139
|
0.0057 pregnancies / cumulative exposure
Interval 0.0026 to 0.0128
|
0.0154 pregnancies / cumulative exposure
Interval 0.005 to 0.0472
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 8
|
0.0102 pregnancies / cumulative exposure
Interval 0.0058 to 0.0179
|
0.0080 pregnancies / cumulative exposure
Interval 0.004 to 0.016
|
0.0224 pregnancies / cumulative exposure
Interval 0.0084 to 0.0593
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 9
|
0.0152 pregnancies / cumulative exposure
Interval 0.0095 to 0.0245
|
0.0139 pregnancies / cumulative exposure
Interval 0.0081 to 0.0239
|
0.0224 pregnancies / cumulative exposure
Interval 0.0084 to 0.0593
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 10
|
0.0163 pregnancies / cumulative exposure
Interval 0.0103 to 0.0258
|
0.0139 pregnancies / cumulative exposure
Interval 0.0081 to 0.0239
|
0.0298 pregnancies / cumulative exposure
Interval 0.0124 to 0.0712
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 11
|
0.0163 pregnancies / cumulative exposure
Interval 0.0103 to 0.0258
|
0.0139 pregnancies / cumulative exposure
Interval 0.0081 to 0.0239
|
0.0298 pregnancies / cumulative exposure
Interval 0.0124 to 0.0712
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 12
|
0.0174 pregnancies / cumulative exposure
Interval 0.0111 to 0.0272
|
0.0152 pregnancies / cumulative exposure
Interval 0.009 to 0.0256
|
0.0298 pregnancies / cumulative exposure
Interval 0.0124 to 0.0712
|
|
Compliant-Use Life-Table Estimates of Pregnancy Rates Based on 28-Day Cycles and Broken Out by Subpopulations Defined by Participant Weight
Cycle 13
|
0.0208 pregnancies / cumulative exposure
Interval 0.0137 to 0.0315
|
0.0191 pregnancies / cumulative exposure
Interval 0.0119 to 0.0307
|
0.0298 pregnancies / cumulative exposure
Interval 0.0124 to 0.0712
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in the body weight decile group.
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Outcome measures
| Measure |
DR-102: Total
n=2401 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
≤53.1 kg (n=249)
|
0.40 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>53.1 to ≤57.1 kg (n=248)
|
2.42 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>57.1 to ≤60.8 kg (n=249)
|
1.61 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>60.8 to ≤64.0 kg (n=234)
|
1.28 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>64.0 to ≤67.6 kg (n=222)
|
4.05 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>67.6 to ≤72.1 kg (n=249)
|
1.20 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>72.1 to ≤77.4 kg (n=230)
|
2.17 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>77.4 to ≤85.3 kg (n=251)
|
1.99 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>85.3 to ≤97.5 kg (n=236)
|
2.12 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Weight Decile Groups Using the 7-Day Rule
>97.5 to ≤181.4 kg (n=233)
|
2.15 percentage of pregnancies
|
—
|
—
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in body weight decile group.
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Outcome measures
| Measure |
DR-102: Total
n=2333 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
≤53.1 kg (n=240)
|
0.42 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>53.1 to ≤57.1 kg (n=240)
|
2.50 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>57.1 to ≤60.8 kg (n=245)
|
1.63 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>60.8 to ≤64.0 kg (n=227)
|
1.32 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>64.0 to ≤67.6 kg (n=217)
|
4.15 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>67.6 to ≤72.1 kg (n=240)
|
1.25 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>72.1 to ≤77.5 kg (n=226)
|
2.21 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>77.5 to ≤85.3 kg (n=242)
|
2.07 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>85.3 to ≤97.1 kg (n=223)
|
2.24 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Weight Decile Groups Using the 7-Day Rule
>97.1 to ≤181.4 kg (n=233)
|
2.15 percentage of pregnancies
|
—
|
—
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in body weight decile group.
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body weight decile (weight range, in kilograms). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Outcome measures
| Measure |
DR-102: Total
n=2317 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
≤53.1 kg (n=238)
|
0.42 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>53.1 to ≤57.1 kg (n=240)
|
1.67 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>57.1 to ≤60.8 kg (n=244)
|
1.23 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>60.8 to ≤64.0 kg (n=225)
|
0.89 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>64.0 to ≤67.6 kg (n=215)
|
2.79 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>67.6 to ≤72.1 kg (n=237)
|
0.84 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>72.1 to ≤77.5 kg (n=223)
|
2.24 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>77.5 to ≤85.3 kg (n=241)
|
0.83 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>85.3 to ≤97.5 kg (n=228)
|
1.75 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Weight Decile Groups Using the 7-Day Rule
>97.5 to ≤181.4 kg (n=226)
|
2.21 percentage of pregnancies
|
—
|
—
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'All Users' set included PITT participants who completed at least one 28-day cycle. n=number of participants in BMI decile group.
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m\^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Outcome measures
| Measure |
DR-102: Total
n=2401 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
≤20.1 kg/m^2 (n=243)
|
1.65 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>20.1 to ≤21.5 kg/m^2 (n=238)
|
1.68 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>21.5 to ≤22.7 kg/m^2 (n=240)
|
1.67 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>22.7 to ≤23.8 kg/m^2 (n=241)
|
0.83 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>23.8 to ≤25.2 kg/m^2 (n=240)
|
1.25 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>25.2 to ≤26.6 kg/m^2 (n=242)
|
2.07 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>26.6 to ≤28.7 kg/m^2 (n=237)
|
2.11 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>28.7 to ≤31.4 kg/m^2 (n=240)
|
3.33 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>31.4 to ≤35.6 kg/m^2 (n=241)
|
2.49 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in All Users, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>35.6 to ≤68.0 kg/m^2 (n=239)
|
2.09 percentage of pregnancies
|
—
|
—
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. The 'Typical-use' set included PITT participants who completed at least one 28-day cycle and in which no other birth control method (BCM), including condoms, were used. n=number of participants in BMI decile group.
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m\^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets.
Outcome measures
| Measure |
DR-102: Total
n=2333 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>31.4 to ≤35.7 kg/m^2 (n=233)
|
2.58 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
≤20.1 kg/m^2 (n=235)
|
1.70 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>20.1 to ≤21.5 kg/m^2 (n=233)
|
1.72 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>21.5 to ≤22.7 kg/m^2 (n=232)
|
1.72 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>22.7 to ≤23.8 kg/m^2 (n=235)
|
0.85 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>23.8 to ≤25.2 kg/m^2 (n=232)
|
1.29 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>25.2 to ≤26.6 kg/m^2 (n=233)
|
2.15 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>26.6 to ≤28.7 kg/m^2 (n=234)
|
2.14 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>28.7 to ≤31.4 kg/m^2 (n=233)
|
3.43 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Typical-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>35.7 to ≤68.0 kg/m^2 (n=233)
|
2.15 percentage of pregnancies
|
—
|
—
|
SECONDARY outcome
Timeframe: thirteen 28-day cyclesPopulation: Pregnancy Intent-to-Treat Population (PITT) of participants who were 18 to 35 years of age, inclusive, at the Screening Visit. 'Compliant-use' set included PITT participants who completed at least 1 28-day cycle and in which no other BCMs were used, and who were deemed to be compliant, per protocol. n=number of participants in BMI decile group.
Crude pregnancy rate is defined as the percentage of on-drug pregnancies per number of participants in each body mass index (BMI) decile (BMI range, in kg/m\^2). The 7-day rule is a standardized process for calculating pregnancy rates. Seven-day rule: a pregnancy was considered "on drug" if the date of conception was on or after the date of first dose of investigational product (IP), but no more than 7 days after the last tablet was taken; last tablet included combination hormonal or EE tablets. Compliant use: did not skip 2 or more consecutive pills, had an overall compliance with IP administration of at least 80%, and did not use a prohibited medication.
Outcome measures
| Measure |
DR-102: Total
n=2317 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>25.2 to ≤26.6 kg/m^2 (n=233)
|
1.29 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
≤20.1 kg/m^2 (n=233)
|
0.86 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>20.1 to ≤21.5 kg/m^2 (n=231)
|
1.30 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>21.5 to ≤22.7 kg/m^2 (n=239)
|
0.84 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>22.7 to ≤23.8 kg/m^2 (n=225)
|
0.89 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>23.8 to ≤25.2 kg/m^2 (n=232)
|
0.86 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>26.6 to ≤28.7 kg/m^2 (n=229)
|
2.18 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>28.7 to ≤31.4 kg/m^2 (n=232)
|
2.59 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>31.4 to ≤35.7 kg/m^2 (n=233)
|
1.72 percentage of pregnancies
|
—
|
—
|
|
Percentage of On-Drug Pregnancies in Compliant-Use, by Body Mass Index (BMI) Decile Groups Using the 7-Day Rule
>35.7 to ≤68.0 kg/m^2 (n=230)
|
2.17 percentage of pregnancies
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.Population: Safety population (received at least 1 dose of DR-102)
AEs summarized are those that began or worsened after treatment with investigational product (IP). An AE is any untoward medical occurrence in a subject or clinical investigation subject participating in a clinical study and which does not necessarily have to have a causal relationship with this treatment or clinical study. Severity of AEs was assessed as mild, moderate or severe. A severe AE was defined as incapacitating, with inability to perform usual activity. An AE was defined as treatment-related when there is reasonable possibility that the AE was caused by or attributed to the IP and/or a causal relationship cannot be ruled out. An SAE was defined as one that meets any one of the following criteria: fatal or life-threatening; requires or prolongs in-patient hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; important medical event.
Outcome measures
| Measure |
DR-102: Total
n=2765 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Any AE
|
1778 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Severe AEs
|
173 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Treatment-related AEs
|
608 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Deaths
|
0 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Other SAEs
|
46 participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs
Withdrawn From Study Due to AEs
|
234 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (at Enrollment), Endpoint (Week 51/Early Withdrawal)Population: Subset of participants with sufficient tissue at both Baseline and Endpoint biopsies.
A subset of study participants agreed to have baseline and endpoint (Week 51/Early Withdrawal) endometrial biopsies. Results were provided for assessment of endometrial tissue/glands. Atrophic: scant or moderate amount of tissue, consists of tiny strips and wisps of surface endometrium or small tubular glands with scant or absent luminal secretions. Inactive: tubular glands lined by epithelial cells with mild pseudostratified and elongated nuclei. Proliferative: tubular or elongated glands lined by cells with elongated, dense, pseudostratified nuclei. Secretory: glands are tortuous or coiled with subnuclear vacuolation, secretion, and intraluminal tufts. Hyperplasia: proliferative type of glands showing glandular crowding with irregular shapes and sizes of enlargement, budding, and branching. Menstrual: glandular and stromal breakdown with fibrin thrombi in small vessels, condensed and collapsed stroma, and necrotic debris.
Outcome measures
| Measure |
DR-102: Total
n=72 Participants
All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
DR-102: Baseline Body Weight <90 kg
n=72 Participants
Subpopulation of total participants with a Baseline body weight \<90 kg
|
DR-102: Baseline Body Weight ≥90 kg
Subpopulation of total participants with a Baseline body weight ≥90 kg
|
|---|---|---|---|
|
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Atrophic
|
10 participants
|
47 participants
|
—
|
|
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Inactive
|
13 participants
|
6 participants
|
—
|
|
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Proliferative
|
11 participants
|
9 participants
|
—
|
|
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Secretory
|
38 participants
|
10 participants
|
—
|
|
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Hyperplasia
|
0 participants
|
0 participants
|
—
|
|
Endometrial Biopsy Classification Results for Endometrial Tissue/Glands at Baseline and Endpoint
Menstrual Endometrium
|
0 participants
|
0 participants
|
—
|
Adverse Events
DR-102
Serious events: 46 serious events
Other events: 1319 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DR-102
n=2765 participants at risk
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
General disorders
Non-cardiac chest pain
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
3/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Immune system disorders
Anaphylactic shock
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Immune system disorders
Food allergy
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Appendicitis
|
0.11%
3/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Pneumonia
|
0.07%
2/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Meningitis viral
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Rectal abscess
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Sepsis
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Toxic shock syndrome streptococcal
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Investigations
Alpha 1 foetoprotein increased
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Investigations
Foetal heart rate decreased
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.07%
2/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phyllodes tumour
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Nervous system disorders
Migraine
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Nervous system disorders
Narcolepsy
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Nervous system disorders
Polyneuropathy
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.18%
5/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Depression
|
0.07%
2/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Bipolar disorder
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Panic disorder with agoraphobia
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.07%
2/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.11%
3/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Vascular disorders
Deep vein thrombosis
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.04%
1/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
Other adverse events
| Measure |
DR-102
n=2765 participants at risk
desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
4.7%
130/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
47/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
247/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Upper respiratory infection
|
6.2%
172/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Sinusitus
|
5.5%
152/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
130/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
4.6%
128/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Vaginitis bacterial
|
3.8%
105/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Bronchitis
|
2.4%
67/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Pharyngitis streptococcal
|
2.0%
55/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Gastroenteritis viral
|
1.9%
53/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Infections and infestations
Influenza
|
1.5%
42/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Investigations
Weight increased
|
3.9%
108/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Investigations
Human papilloma virus test positive
|
1.6%
43/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Nervous system disorders
Headache
|
4.8%
132/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Nervous system disorders
Migraine
|
1.8%
51/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Anxiety
|
2.0%
54/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Psychiatric disorders
Depression
|
1.6%
43/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
4.4%
121/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
4.1%
114/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
3.0%
82/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.7%
46/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.6%
72/2765 • Serious adverse Event (SAE) reporting period began upon signed informed consent and ended at the Final Study or the Early Withdrawal Visit. AEs were reported at each study visit (Weeks 0 through Week 53). Treatment duration with IP was up to one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator/Institution must submit proposed publication to Sponsor for review within a prespecified number of days before submission for publication. If Sponsor's review shows that potentially patentable subject matter would be disclosed, publication/public disclosure shall be delayed to enable Sponsor, or Sponsor's designees, to file necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER