Trial Outcomes & Findings for A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women (NCT NCT01252186)
NCT ID: NCT01252186
Last Updated: 2015-03-13
Results Overview
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
265 participants
Primary outcome timeframe
Baseline to Month 6
Results posted on
2015-03-13
Participant Flow
Participant milestones
| Measure |
91-day Levonorgestrel Oral Contraceptive
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Overall Study
STARTED
|
87
|
91
|
87
|
|
Overall Study
Received Study Drug
|
83
|
89
|
80
|
|
Overall Study
COMPLETED
|
57
|
59
|
53
|
|
Overall Study
NOT COMPLETED
|
30
|
32
|
34
|
Reasons for withdrawal
| Measure |
91-day Levonorgestrel Oral Contraceptive
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
9
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Non-compliance
|
0
|
3
|
4
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
2
|
2
|
0
|
|
Overall Study
Sponsor Request
|
2
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
10
|
11
|
|
Overall Study
Other - Miscellaneous Reasons
|
5
|
5
|
7
|
Baseline Characteristics
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
Baseline characteristics by cohort
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=75 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=80 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=71 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 5.87 • n=99 Participants
|
26.8 years
STANDARD_DEVIATION 6.22 • n=107 Participants
|
27.0 years
STANDARD_DEVIATION 5.75 • n=206 Participants
|
27.0 years
STANDARD_DEVIATION 5.94 • n=7 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
226 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
5 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
9 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
42 participants
n=99 Participants
|
39 participants
n=107 Participants
|
40 participants
n=206 Participants
|
121 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 participants
n=99 Participants
|
20 participants
n=107 Participants
|
19 participants
n=206 Participants
|
52 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Per-Protocol (PP) Population included all data from ITT participants obtained prior to experiencing major protocol violations.
Prothrombin fragment 1+2 is a coagulation factor, released when prothrombin is cleaved by activated factor X. Elevated plasma levels of prothrombin fragment 1+2 indicate high risk of thrombosis.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Prothrombin Fragment 1+2 Levels
|
169.53 pmol/L
Standard Error 155.15
|
157.99 pmol/L
Standard Error 150.11
|
592.29 pmol/L
Standard Error 160.32
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
D-dimer is the degradation product of cross-linked fibrin and is a marker of thrombin and fibrin formation and turnover.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in D-dimer
|
86.74 ng/mL
Standard Error 31.49
|
72.43 ng/mL
Standard Error 30.18
|
158.05 ng/mL
Standard Error 32.07
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
The plasmin-antiplasmin (PAP) complex is a marker of thrombin and fibrin formation and turnover.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Plasmin-Antiplasmin (PAP) Complex
|
10.72 ng/mL
Standard Error 44.55
|
-6.42 ng/mL
Standard Error 43.11
|
107.81 ng/mL
Standard Error 45.97
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population with available data
The APC resistance assay is a clotting test that measures the ratio of APTT clotting times in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of the clotting time after APC addition over the clotting time with no APC addition. APC resistance is defined as a poor anticoagulant response of plasma to APC (minimal prolongation of the APTT) and a correspondingly low ratio.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=58 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Activated Partial Thromboplastin Time (APTT) Based Activated Protein-C Resistance (APC)
|
-0.12 ratio
Standard Error 0.04
|
-0.15 ratio
Standard Error 0.03
|
-0.27 ratio
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
This assay is based on measurement of the effect of activated protein C on the endogenous thrombin potential, the time integral of thrombin generation initiated in plasma through the extrinsic coagulation pathway. The APC resistance assay measures the ratio of endogenous thrombin potential in the presence and absence of a standard amount of exogenous APC. APC resistance is calculated as the ratio of EPT after APC addition over the EPT with no APC addition. APC resistance is defined as a poor anticoagulant response of plasma to APC (less inhibition of thrombin formation) and a correspondingly higher ratio.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Endogenous Thrombin Potential (EPT) Based Activated Protein-C Resistance (APC)
|
0.38 ratio
Standard Error 0.05
|
0.37 ratio
Standard Error 0.05
|
0.57 ratio
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Fibrinogen (factor I) is a glycoprotein that helps in the formation of blood clots.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Fibrinogen
|
0.12 g/L
Standard Error 0.07
|
0.22 g/L
Standard Error 0.06
|
-0.04 g/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Plasminogen is the precursor of plasmin, which lyses fibrin clots.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Plasminogen
|
0.04 g/L
Standard Error 0.00
|
0.04 g/L
Standard Error 0.00
|
0.04 g/L
Standard Error 0.00
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Tissue plasminogen activator catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for the breakdown of blood clots.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Tissue Plasminogen Activator (t-PA)
|
-0.91 µg/L
Standard Error 0.32
|
-1.48 µg/L
Standard Error 0.30
|
-9.3 µg/L
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Clotting factor II, also called prothrombin, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Factor II
|
6.89 percentage of normal
Standard Error 1.73
|
7.98 percentage of normal
Standard Error 1.65
|
8.57 percentage of normal
Standard Error 1.76
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Clotting factor VII, also called proconvertin or autoprothrombin I, functions in blood coagulation. Results are reported as percent of normal plasma concentrations. By definition, normal plasma contains 100% (1 unit/mL) of each factor. The reference range is approximately 60% to 140% for adults.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Factor VII
|
14.27 percentage of normal
Standard Error 7.52
|
22.98 percentage of normal
Standard Error 7.18
|
43.22 percentage of normal
Standard Error 7.67
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Clotting factor VIII, also known as anti-hemophilic factor (AHF), functions in blood coagulation by stabilizing fibrin clots. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%.for adults.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Factor VIII
|
-3.23 percentage of normal
Standard Error 2.98
|
0.08 percentage of normal
Standard Error 2.87
|
5.53 percentage of normal
Standard Error 3.05
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Antithrombin is a protein in the blood that naturally blocks blood clots from forming. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 80% to 130%.for adults.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Antithrombin
|
2.36 percentage of normal
Standard Error 1.00
|
-0.05 percentage of normal
Standard Error 0.98
|
-0.83 percentage of normal
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% for adults.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Protein C Activity
|
-6.15 percentage of normal
Standard Error 2.62
|
-4.39 percentage of normal
Standard Error 2.53
|
-2.41 percentage of normal
Standard Error 2.70
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Protein C helps to regulate blood clot formation. Activated Protein C (APC) combines with Protein S (a cofactor) to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140% in adults.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Protein C Antigen
|
12.83 percentage of normal
Standard Error 2.26
|
11.97 percentage of normal
Standard Error 2.17
|
10.00 percentage of normal
Standard Error 2.32
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with Protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Free Protein S
|
2.96 percentage of normal
Standard Error 2.13
|
4.62 percentage of normal
Standard Error 2.03
|
-18.2 percentage of normal
Standard Error 2.17
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Protein S helps to regulate blood clot formation. Protein S exists in two forms: a free form and a complex form. Free protein S combines with activated protein C to degrade coagulation factors VIIIa and Va, slowing down the generation of new thrombin and inhibiting further clotting. Results are reported as a percent of the amount expected in normal plasma. By definition, the mean value in normal plasma is 100%. The reference range is approximately 70% to 140%; lower for women than for men.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Total Protein S
|
-11.06 percentage of normal
Standard Error 1.51
|
-11.48 percentage of normal
Standard Error 1.45
|
-21.59 percentage of normal
Standard Error 1.55
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Tissue Factor Pathway Inhibitor (TFPI) is an anti-coagulation protein that binds to activated protein X.
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Tissue Factor Pathway Inhibitor (TFPI)
|
4.65 ng/mL
Standard Error 1.26
|
2.54 ng/mL
Standard Error 1.21
|
-1.34 ng/mL
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Baseline top Month 6Population: Per-protocol population with available data
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=58 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Thyroid Stimulating Hormone (TSH)
|
-0.22 mIU/L
Standard Error 0.13
|
0.10 mIU/L
Standard Error 0.13
|
0.22 mIU/L
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=59 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Total Cortisol
|
217.94 nmol/L
Standard Error 24.39
|
262.40 nmol/L
Standard Error 23.39
|
227.68 nmol/L
Standard Error 24.96
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population with available data
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=67 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=58 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Corticosteroid Binding Globulin
|
576.33 nmol/L
Standard Error 45.37
|
563.85 nmol/L
Standard Error 43.41
|
634.64 nmol/L
Standard Error 46.74
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Per-protocol population with available data
Outcome measures
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=61 Participants
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=66 Participants
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=58 Participants
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Change From Baseline to End of Month 6 in Sex Hormone Binding Globulin (SHBG)
|
34.87 mIU/L
Standard Error 8.40
|
30.85 mIU/L
Standard Error 8.08
|
165.01 mIU/L
Standard Error 8.67
|
Adverse Events
91-day Levonorgestrel Oral Contraceptive
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
28-day Levonorgestrel Oral Contraceptive
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
28-day Desogestrel Oral Contraceptive
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
91-day Levonorgestrel Oral Contraceptive
n=83 participants at risk
Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
|
28-day Levonorgestrel Oral Contraceptive
n=89 participants at risk
Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
28-day Desogestrel Oral Contraceptive
n=80 participants at risk
Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
5/83 • Number of events 5 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
4.5%
4/89 • Number of events 5 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
10.0%
8/80 • Number of events 9 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/83 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
2.2%
2/89 • Number of events 2 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
5.0%
4/80 • Number of events 4 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
|
Investigations
Prothrombin level increased
|
0.00%
0/83 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
1.1%
1/89 • Number of events 1 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
5.0%
4/80 • Number of events 4 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
|
Nervous system disorders
Headache
|
3.6%
3/83 • Number of events 3 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
1.1%
1/89 • Number of events 1 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
5.0%
4/80 • Number of events 4 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
|
Reproductive system and breast disorders
Metrorrhagia
|
13.3%
11/83 • Number of events 14 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
3.4%
3/89 • Number of events 3 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
2.5%
2/80 • Number of events 2 • From the first dose of study drug until 14 days after the last dose (up to 27 weeks).
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the 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