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:
Teva Women's Health
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Women's Health )
ClinicalTrials.gov Identifier:
NCT01388491
First received: July 1, 2011
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
This study is being conducted to evaluate the impact of a 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:
MedlinePlus related topics:
Women's Health
Drug Information available for:
Estradiol
Ethinyl Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
Desogestrel
U.S. FDA Resources
Further study details as provided by Teva Pharmaceutical Industries:
Primary Outcome Measures:
- Change from baseline to end of month 6 in Prothrombin fragment 1+2 levels [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 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 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 Antithrombin [ 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 sex hormone binding globulin (SHBG) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 293 |
| Study Start Date: | October 2011 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 28-day Oral Contraceptive |
Drug: Desogestrel/ethinyl estradiol and ethinyl estradiol
Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
|
| Active Comparator: 28-day Desogestrel Oral Contraceptive |
Drug: Desogestrel/ethinyl estradiol
Desogestrel/ethinyl estradiol 0.15/0.02 mg
|
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 Women's Health
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 Women's Health ) |
| ClinicalTrials.gov Identifier: | NCT01388491 History of Changes |
| Other Study ID Numbers: | DSG-HSP-201 |
| Study First Received: | July 1, 2011 |
| Last Updated: | January 24, 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 May 16, 2013