A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
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| ClinicalTrials.gov Identifier: NCT01388491 |
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Recruitment Status :
Completed
First Posted : July 6, 2011
Results First Posted : November 27, 2013
Last Update Posted : December 6, 2021
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Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemostasis Oral Contraceptive | Drug: desogestrel/ethinyl estradiol and ethinyl estradiol Drug: desogestrel/ethinyl estradiol | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 293 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 Hemosatic Parameters in Healthy Women |
| Actual Study Start Date : | October 31, 2011 |
| Actual Primary Completion Date : | September 30, 2012 |
| Actual Study Completion Date : | September 30, 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: desogestrel/ethinyl estradiol and ethinyl estradiol |
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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
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Drug: desogestrel/ethinyl estradiol |
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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388491
Locations
Show 27 study locations
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 |
Publications of Results:
| Responsible Party: | Teva Branded Pharmaceutical Products R&D, Inc. |
| ClinicalTrials.gov Identifier: | NCT01388491 |
| Other Study ID Numbers: |
DSG-HSP-201 |
| First Posted: | July 6, 2011 Key Record Dates |
| Results First Posted: | November 27, 2013 |
| Last Update Posted: | December 6, 2021 |
| Last Verified: | December 2021 |
Keywords provided by Teva Branded Pharmaceutical Products R&D, Inc.:
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Contraception Hemostasis Blood Coagulation |
Additional relevant MeSH terms:
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Estradiol 17 beta-cypionate Estradiol 3-benzoate Ethinyl Estradiol Desogestrel Estradiol Polyestradiol phosphate Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Contraceptive Agents, Hormonal Contraceptive Agents Reproductive Control Agents Contraceptive Agents, Female Contraceptives, Oral, Hormonal Contraceptives, Oral Contraceptives, Oral, Synthetic Progestins |