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Desogestrel/ethinyl estradiol and ethinyl estradiol

Phase 2

Hemostasis | Small molecule | Hematology |Teva Pharmaceutical Industries Limited|Last Updated: Dec 8, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment293

FDA Designations

No designations recorded

Clinical trial landscape

Desogestrel/ethinyl estradiol and ethinyl estradiol · 2 trials · 6 indications

Phase 2 1Phase 1 1
NCT01388491A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy WomenHemostasis
COMPLETED293 Analytics
PHASE2COMPLETED
A Multinational Study to Evaluate the Effects of a 28-Day Oral Contraceptive on Hemostatic Parameters in Healthy Women
Hemostasis
NCT01388491293
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Study Endpoints

Primary Endpoints

Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Prothrombin Fragment 1 + 2 Levels
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.

Evaluation of ovarian follicular development by the Hoogland and Skouby grading scale from baseline to week 16.
16 weeks
Change in serum Estradiol level from baseline to week 16.
16 weeks
Change in serum Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) levels from baseline to week 16.
16 weeks
Change in serum Progesterone level from baseline to week 20.
20 weeks

Secondary Endpoints

Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in D-Dimer
Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Period in Protein S Total Antigen
Baseline through Month 6
Least Squares Mean Change From Baseline Over the 6-Month Treatment Period in Protein C Activity
Baseline through Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Treatment I: (DR-102)EXPERIMENTAL21 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
Treatment IIACTIVE_COMPARATOR21 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
28-day Desogestrel Oral ContraceptiveEXPERIMENTAL -
28-day Drospirenone Oral ContraceptiveACTIVE_COMPARATOR -
28-day Levonorgestrel Oral ContraceptiveACTIVE_COMPARATOR -

Interventions

NameTypeDescription
desogestrel/ethinyl estradiol and ethinyl estradiolDRUG -
desogestrel/ethinyl estradiolDRUG -
28-day drospirenone oral contraceptiveDRUGDrospirenone/ethinyl estradiol 0.3/0.02 mg
28-day levonorgestrel oral contraceptiveDRUGLevonorgestrel/ethinyl estradiol 0.1/0.02 mg
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Eligibility Criteria

Age Range18 Years to 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites27

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 comb...

Countries:GermanyIsraelItalySpainUnited States
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