Trial Outcomes & Findings for A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women (NCT NCT01388491)
NCT ID: NCT01388491
Last Updated: 2021-12-06
Results Overview
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
COMPLETED
PHASE2
293 participants
Baseline through Month 6
2021-12-06
Participant Flow
Of the 351 healthy women screened for enrollment, 293 at 26 centers in the European Union (EU) (21 centers) and Israel (5 centers) met entry criteria and were considered to be eligible for this study.
Of the 58 women who were screened but not randomly assigned to receive treatment, 10 were excluded on the basis of inclusion/exclusion criteria, 32 withdrew consent, and 6 were lost to follow-up before the baseline visit. An additional 10 participants were not randomly assigned to treatment for other reasons.
Participant milestones
| Measure |
Treatment I: (DR-102)
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
143
|
|
Overall Study
Safety Population
|
145
|
142
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
140
|
136
|
|
Overall Study
Per Protocol (PP) Population
|
125
|
121
|
|
Overall Study
COMPLETED
|
116
|
114
|
|
Overall Study
NOT COMPLETED
|
34
|
29
|
Reasons for withdrawal
| Measure |
Treatment I: (DR-102)
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
9
|
|
Overall Study
Sponsor Request
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Noncompliance
|
2
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
Baseline Characteristics
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
Baseline characteristics by cohort
| Measure |
Treatment I: (DR-102)
n=145 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=142 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
Total
n=287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 4.98 • n=5 Participants
|
27.0 years
STANDARD_DEVIATION 5.26 • n=7 Participants
|
26.7 years
STANDARD_DEVIATION 5.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
140 participants
n=5 Participants
|
136 participants
n=7 Participants
|
276 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Weight
|
61.6 kg
STANDARD_DEVIATION 10.35 • n=5 Participants
|
60.1 kg
STANDARD_DEVIATION 9.36 • n=7 Participants
|
60.9 kg
STANDARD_DEVIATION 9.89 • n=5 Participants
|
|
Body Mass Index (BMI)
|
22.9 kg/m^2
STANDARD_DEVIATION 3.62 • n=5 Participants
|
22.4 kg/m^2
STANDARD_DEVIATION 3.06 • n=7 Participants
|
22.6 kg/m^2
STANDARD_DEVIATION 3.36 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Month 6Population: Per-protocol (PP) population. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=125 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=121 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
|
45.0 pmol/L
Standard Error 15.24
|
56.8 pmol/L
Standard Error 15.60
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=118 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=114 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer
|
16.4 mcg/L
Standard Error 10.29
|
13.4 mcg/L
Standard Error 10.46
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=124 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=121 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen
|
-11.4 percentage of normal 50% to 147%
Standard Error 1.09
|
-6.6 percentage of normal 50% to 147%
Standard Error 1.10
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=124 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=121 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity
|
16.3 percentage of normal
Standard Error 1.90
|
13.0 percentage of normal
Standard Error 1.93
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=124 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=121 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin
|
-1.6 percentage of normal
Standard Error 1.17
|
-3.2 percentage of normal
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=118 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=114 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity
|
3.3 percentage of normal
Standard Error 0.21
|
3.0 percentage of normal
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=118 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=114 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII
|
17.9 percentage of normal
Standard Error 0.81
|
15.1 percentage of normal
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=118 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=114 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII
|
11.1 percentage of normal
Standard Error 1.92
|
10.6 percentage of normal
Standard Error 1.95
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=124 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=120 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance
|
-0.3 ratio
Standard Error 0.02
|
-0.4 ratio
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=124 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=121 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance
|
0.8 ratio
Standard Error 0.04
|
0.7 ratio
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=122 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=117 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin
|
4083.3 mg/L
Standard Error 159.45
|
3721.8 mg/L
Standard Error 162.95
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=125 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=120 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol
|
239.0 nmol/L
Standard Error 15.67
|
230.8 nmol/L
Standard Error 16.03
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=125 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=120 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)
|
0.2 mIU/L
Standard Error 0.07
|
0.3 mIU/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline through Month 6Population: Per protocol (PP) population with BL and at least 1 post-BL value for this measurement. PP population included all data from intent-to-treat (ITT) participants obtained prior to any major protocol violations. PP participants were analyzed according to the treatment actually received.
Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction.
Outcome measures
| Measure |
Treatment I: (DR-102)
n=125 Participants
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=120 Participants
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin
|
163.4 nmol/L
Standard Error 7.29
|
149.1 nmol/L
Standard Error 7.46
|
Adverse Events
Treatment I: (DR-102)
Treatment II
Serious adverse events
| Measure |
Treatment I: (DR-102)
n=145 participants at risk
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=142 participants at risk
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
0.70%
1/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
Other adverse events
| Measure |
Treatment I: (DR-102)
n=145 participants at risk
21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
|
Treatment II
n=142 participants at risk
21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.8%
4/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
1.4%
2/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
3/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.1%
3/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Infections and infestations
Gastroenteritis
|
0.69%
1/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.8%
4/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Infections and infestations
Influenza
|
0.69%
1/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.8%
4/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Infections and infestations
Urinary tract infection
|
0.69%
1/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.1%
3/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Investigations
Alpha globulin increased
|
7.6%
11/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
5.6%
8/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Investigations
Prothrombin level increased
|
5.5%
8/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
4.9%
7/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Investigations
Antithrombin III decreased
|
0.69%
1/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.1%
3/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Nervous system disorders
Headache
|
6.2%
9/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
11.3%
16/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Nervous system disorders
Dizziness
|
2.8%
4/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
0.00%
0/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Psychiatric disorders
Libido decreased
|
2.1%
3/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
0.70%
1/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
34.5%
50/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
19.7%
28/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Reproductive system and breast disorders
Breast pain
|
3.4%
5/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
1.4%
2/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.8%
4/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
4.9%
7/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Reproductive system and breast disorders
Menorrhagia
|
2.8%
4/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
0.70%
1/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.69%
1/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.1%
3/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.69%
1/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
2.1%
3/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.8%
4/145 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
1.4%
2/142 • Adverse events/serious adverse events were collected from the time of signed informed consent until the the Final Telephone Contact (14 days after completing investigational product) or the Early Termination Visit. Treatment period was 6 28-day cycles.
|
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