A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT01252186
First received: November 30, 2010
Last updated: May 2, 2013
Last verified: May 2013

November 30, 2010
May 2, 2013
November 2010
January 2012   (final data collection date for primary outcome measure)
Change from baseline to end of month 6 in Prothrombin fragment 1+2 levels. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01252186 on ClinicalTrials.gov Archive Site
  • Change from baseline to end of month 6 in D-dimer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasmin-Antiplasmin complex [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in activated partial thromboplastin time (APTT) and etoposide (ETP) based activated protein-C resistance (APC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Fibrinogen [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Plasminogen Activator (t-PA) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Antithrombin [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Factor Pathway Inhibitor (TFPI) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in sex hormone binding globulin (SHBG) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in total cortisol and corticosteroid binding globulin (CBG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in thyroid stimulating hormone (TSH) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in D-dimer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasmin-Antiplasmin complex [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in APTT and ETP based activated protein-C resistance (APC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Fibrinogen [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Plasminogen, Factor II, Factor VII, Factor VIII, Protein C, and Free and Total Protein S [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Plasminogen Activator (t-PA) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Antithrombin [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in Tissue Factor Pathway Inhibitior (TFPI) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in sex hormone binding globulin (SHBG) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in total cortisol and corticosteroid binding globulin (CBG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to end of month 6 in thyroid stimulating hormone (TSH) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-Day Extended Cycle Oral Contraceptive Regimen, Compared to Two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women.

This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Hemostasis
  • Oral Contraceptive
  • Drug: Levonorgestrel/ethinyl estradiol and ethinyl estradiol
    Levonorgestrel/ethinyl estradiol 0.15/0.03 mg and ethinyl estradiol 0.01 mg tablet.
    Other Name: Seasonique®
  • Drug: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg.
    1 tablet daily
    Other Name: Minidril®
  • Drug: Desogestrel/ethinyl estradiol 0.15/0.03 mg
    1 Tablet Daily
    Other Name: Marvelon®
  • Experimental: 91-day Levonorgestrel Oral Contraceptive
    Intervention: Drug: Levonorgestrel/ethinyl estradiol and ethinyl estradiol
  • Active Comparator: 28-day Levonorgestrel Oral Contraceptive
    Intervention: Drug: Levonorgestrel/ethinyl estradiol 0.15/0.03 mg.
  • Active Comparator: 28-day Desogestrel Oral Contraceptive
    Intervention: Drug: Desogestrel/ethinyl estradiol 0.15/0.03 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
February 2012
January 2012   (final data collection date for primary outcome measure)

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
  • Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III deficiency
  • Others as dictated by FDA-approved protocol
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT01252186
PSE-HSP-203, 2010-023215-34
No
Teva Pharmaceutical Industries ( Teva Women's Health )
Teva Women's Health
Not Provided
Study Chair: Teva Women's Health Research Protocol Chair Teva Women's Health Research
Teva Pharmaceutical Industries
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP