Recent Updates
Recently added Catalysts

Levonorgestrel/Ethinyl Estradiol

Phase 3

Premenstrual Syndrome | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 8, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment726
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00195559Study Evaluating Combination of Levonorgestrel and Ethinyl Estradiol in Pre-Menstrual Dysphoric DisorderPHASE3 COMPLETED 526 — — Sep 1, 2005Dec 1, 2007Dec 27, 200751 Argentina, Brazil +10
NCT00161681Study Evaluating Levonorgestrel/Ethinyl Estradiol (LNG/EE) in PMSPHASE3 COMPLETED 200 — — Jul 1, 2005Aug 1, 2006Feb 8, 201348 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Mean change in average Daily Record of Severity of Problems (DRSP) 21-item total daily score
To evaluate the efficacy of a continuous-use OC regimen containing a combination of LNG/EE in preventing moderate to severe cycle-related symptoms compared with placebo
Secondary Endpoints
Change from baseline in DRSP 21-item daily score based on the 5 days with the highest DRSP scores in each "estimated" treatment cycle
To evaluate the effects of this LNG/EE regimen on work productivity and subject satisfaction in subjects with moderate to severe cycle-related symptoms at baseline compared with placebo
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Levonorgestrel/Ethinyl EstradiolDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 49 Years
SexFEMALE
Healthy VolunteersNo
Study Sites51

Inclusion Criteria: * Generally healthy, women aged 18 to 49 years. * History of severe PMS symptoms over the last year, as determined by the investigator. * Regular 21 to 35 day menstrual cycle for 2 months prior to first study visit. Exclusion Criteria: * Major depressive disorder requiring ant...

Countries:ArgentinaBrazilChileDenmarkFinlandGermanyMexicoNetherlandsPolandRomaniaSwedenUnited KingdomUnited States
Unlock Eligibility Criteria