Clinical trial NCT01388491: A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemostasis
Oral Contraceptive
Keywords: Contraception
Hemostasis
Blood Coagulation
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 293
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Antithrombin
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor II Activity
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VII
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Factor VIII
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Activated Partial Thromboplastin Time (APTT)-Based Activated Protein-C (APC) Resistance
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Endogenous Thrombin Potential (EPT)-Based Activated Protein-C (APC) Resistance
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Corticosteroid-Binding Globulin
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Serum Random Total Cortisol
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Thyroid-Stimulating Hormone (TSH)
timeFrame: Baseline through Month 6
measure: Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Sex Hormone Binding Globulin
timeFrame: Baseline through Month 6
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Teva Investigational Site 32064
city: Frankfurt am Main
country: Germany
facility: Teva Investigational Site 32066
city: Frankfurt
country: Germany
facility: Teva Investigational Site 32065
city: Hamburg
country: Germany
facility: Teva Investigational Site 32062
city: Hamburg
country: Germany
facility: Teva Investigational Site 32063
city: Magdeburg
country: Germany
facility: Teva Investigational Site 32061
city: Givataim
country: Israel
facility: Teva Investigational Site 80013
city: Haifa
country: Israel
facility: Teva Investigational Site 80015
city: Modi'in
country: Israel
facility: Teva Investigational Site 80017
city: RishonLe'zio
country: Israel
facility: Teva Investigational Site 80014
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80018
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 80016
city: Brescia
country: Italy
facility: Teva Investigational Site 30014
city: Cagliari
country: Italy
facility: Teva Investigational Site 30009
city: Catania
country: Italy
facility: Teva Investigational Site 30012
city: Napoli
country: Italy
facility: Teva Investigational Site 30013
city: Pavia
country: Italy
facility: Teva Investigational Site 30010
city: Pisa
country: Italy
facility: Teva Investigational Site 30007
city: Siena
country: Italy
facility: Teva Investigational Site 30016
city: Barcelona
country: Spain
facility: Teva Investigational Site 31017
city: Barcelona
country: Spain
facility: Teva Investigational Site 31015
city: Barcelona
country: Spain
facility: Teva Investigational Site 31014
city: Gava, Barcelona
country: Spain
facility: Teva Investigational Site 31016
city: Lugo
country: Spain
facility: Teva Investigational Site 31012
city: Madrid
country: Spain
facility: Teva Investigational Site 31010
city: Madrid
country: Spain
facility: Teva Investigational Site 31011
city: Vitoria-Gasteiz
country: Spain
facility: Teva Investigational Site 31009
Study officials:
affiliation: Teva Women's Health Research
name: Teva Women's Health Research Protocol Chair
role: STUDY_CHAIR
References:
citation: Peters K, Gordon N, Ricciotti N, Hsieh J, Howard B, Weiss H. Hemostatic effects of two desogestrel-containing combined oral contraceptive regimens: a multinational, multicenter, randomized, open-label study. Clin Exp Obstet Gynecol. 2016;43(3):334-40.