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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01388491
First received: July 1, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Hemostasis
Oral Contraceptive
Drug: desogestrel/ethinyl estradiol and ethinyl estradiol
Drug: desogestrel/ethinyl estradiol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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 Hemostatic Parameters in Healthy Women

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH) [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.

  • Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin [ Time Frame: Baseline through Month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 293
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: desogestrel/ethinyl estradiol and ethinyl estradiol
Active Comparator: 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
Drug: desogestrel/ethinyl estradiol

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388491

Locations
Germany
Teva Investigational Site
Essen, Germany, 45127
Teva Investigational Site
Frankfurt, Germany
Teva Investigational Site
Frankfurt am Main, Germany, 60439
Teva Investigational Site
Hamburg, Germany, 22149
Teva Investigational Site
Hamburg, Germany, 22159
Teva Investigational Site
Magdeburg, Germany, 39112
Teva Investigational Site
Muehlheim am Main, Germany, 63165
Israel
Teva Investigational Site
Givataim, Israel
Teva Investigational Site
Haifa, Israel
Teva Investigational Site
Modi'in, Israel
Teva Investigational Site
Or-Yehuda, Israel
Teva Investigational Site
RishonLe'zio, Israel
Teva Investigational Site
Tel-Aviv, Israel
Italy
Teva Investigational Site
Bari, Italy, 70124
Teva Investigational Site
Brescia, Italy, 25123
Teva Investigational Site
Cagliari, Italy, 09124
Teva Investigational Site
Catania, Italy, 95123
Teva Investigational Site
Modena, Italy, 41124
Teva Investigational Site
Napoli, Italy, 80131
Teva Investigational Site
Padova, Italy, 35128
Teva Investigational Site
Pavia, Italy, 27100
Teva Investigational Site
Pisa, Italy, 56126
Teva Investigational Site
Siena, Italy, 53100
Spain
Teva Investigational Site
Alicante, Spain
Teva Investigational Site
Barcelona, Spain
Teva Investigational Site
Gava', Barcelona, Spain
Teva Investigational Site
Guadalajara, Spain
Teva Investigational Site
Lugo, Spain
Teva Investigational Site
Madrid, Spain
Teva Investigational Site
Vitoria-Gasteiz, Spain
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Chair: Teva Women's Health Research Protocol Chair Teva Women's Health Research
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01388491     History of Changes
Other Study ID Numbers: DSG-HSP-201
Study First Received: July 1, 2011
Results First Received: September 23, 2013
Last Updated: September 23, 2013
Health Authority: Italy: Competent Authority
United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Contraception
Hemostasis
Blood Coagulation

Additional relevant MeSH terms:
Contraceptive Agents
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Desogestrel
Contraceptives, Oral
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Hemostatics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Coagulants
Hematologic Agents
Progestins
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on April 17, 2014