A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women

Hemostasis Clinical Trial

Official title:

A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemosatic Parameters in Healthy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388491
• Other study ID #: DSG-HSP-201
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2011
• Est. completion date: September 30, 2012

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: September 30, 2012
• Est. primary completion date: September 30, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Premenopausal, non-pregnant, non-lactating women age 18-40 years old

• Body Mass Index (BMI) =18 kg/m² and <30 kg/m²

• Regular spontaneous menstrual cycle

• Others as dictated by FDA-approved protocol

Exclusion Criteria:

• Any condition which contraindicates the use of combination oral contraceptives

• Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease within one year of screening

• Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenetic valvulopathies or rhythm disorders

• Others as dictated by FDA-approved protocol

Related Conditions & MeSH terms

• Hemostasis
• Oral Contraceptive

Intervention

Drug:
• desogestrel/ethinyl estradiol and ethinyl estradiol

• desogestrel/ethinyl estradiol

Locations

Country	Name	City	State
Germany	Teva Investigational Site 32064	Essen
Germany	Teva Investigational Site 32065	Frankfurt
Germany	Teva Investigational Site 32066	Frankfurt am Main
Germany	Teva Investigational Site 32062	Hamburg
Germany	Teva Investigational Site 32063	Hamburg
Germany	Teva Investigational Site 32061	Magdeburg
Israel	Teva Investigational Site 80013	Givataim
Israel	Teva Investigational Site 80015	Haifa
Israel	Teva Investigational Site 80017	Modi'in
Israel	Teva Investigational Site 80014	RishonLe'zio
Israel	Teva Investigational Site 80016	Tel-Aviv
Israel	Teva Investigational Site 80018	Tel-Aviv
Italy	Teva Investigational Site 30014	Brescia
Italy	Teva Investigational Site 30009	Cagliari
Italy	Teva Investigational Site 30012	Catania
Italy	Teva Investigational Site 30013	Napoli
Italy	Teva Investigational Site 30010	Pavia
Italy	Teva Investigational Site 30007	Pisa
Italy	Teva Investigational Site 30016	Siena
Spain	Teva Investigational Site 31014	Barcelona
Spain	Teva Investigational Site 31015	Barcelona
Spain	Teva Investigational Site 31017	Barcelona
Spain	Teva Investigational Site 31016	Gava, Barcelona
Spain	Teva Investigational Site 31012	Lugo
Spain	Teva Investigational Site 31010	Madrid
Spain	Teva Investigational Site 31011	Madrid
Spain	Teva Investigational Site 31009	Vitoria-Gasteiz

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

Germany,  Israel,  Italy,  Spain, 

References & Publications (1)

Ricciotti N, Howard B, Weiss H. Hemostatic effects of two oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Fertil Steril 100(3):S313, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)	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.	Baseline through Month 6
Secondary	Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin	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.	Baseline through Month 6