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

Teva Branded Pharmaceutical Products R&D, Inc.293 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

293

Conditions

Hemostasis Oral Contraceptive

Interventions

desogestrel/ethinyl estradiol and ethinyl estradiolDRUG

desogestrel/ethinyl estradiolDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (27)

Teva Investigational Site 32064

Essen, Germany

Outcomes

Primary Outcomes

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.

Time frame: Baseline through Month 6

Secondary Outcomes

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Data from ClinicalTrials.gov

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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, Germany

Teva Investigational Site 80013

Giv‘atayim, Israel

Teva Investigational Site 80015

Haifa, Israel

Teva Investigational Site 80017

Modiin, Israel

Teva Investigational Site 80014

RishonLe'zio, Israel

...and 17 more locations

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6

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.

Time frame: Baseline through Month 6