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28-day drospirenone contraceptive

Phase 1

Follicle Development | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Dec 8, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment206
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01291004A Study to Evaluate Ovarian Follicular Activity and Hormone Levels for DR-102 Compared to Two 28-Day Oral ContraceptivesPHASE1 COMPLETED 206 — — Jan 31, 2011Mar 31, 2012Dec 8, 20212 United States
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Study Endpoints
Primary Endpoints
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
Change from baseline to week 15 in Prothrombin fragment 1 + 2 levels.
15 weeks
Change from baseline to week 15 in D-dimer.
15 weeks
Change from baseline to end of week 15 in Plasmin-Antiplasmin complex
15 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
28-day Desogestrel Oral ContraceptiveEXPERIMENTAL -
28-day Drospirenone Oral ContraceptiveACTIVE_COMPARATOR -
28-day Levonorgestrel Oral ContraceptiveACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Desogestrel/ethinyl estradiol and ethinyl estradiolDRUGDesogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
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 — 35 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Premenopausal, non-pregnant, non-lactating women age 18-35 years old * Body Mass Index (BMI) ≥18 kg/m² and \<30 kg/m² * Regular spontaneous menstrual cycle * Others as dictated by Food and Drug Administration (FDA)-approved protocol Exclusion Criteria: * Any condition which ...

Countries:United States
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