Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
280
Trial Sponsor
Clinical Trial Start Date
2015
0Primary Completion Date
2016
0Study Completion Date
2016
0Clinical Trial Study Type
Interventional0
Intervention Type
Drug0
Intervention Name
ITCA placebo, ITCA 650 20/60 mcg/day0
ITCA 650 20/60 mcg/day, ITCA placebo0
Interventional Trial Phase
Phase 10
Participating Facility
Official Name
A Phase 1, Randomized, Double-blind, Placebo-Controlled, Crossover Study to Assess the Effect of ITCA 650 on the Pharmacokinetics and Pharmacodynamics of a Combination Oral Contraceptive in Healthy Premenopausal Female Subjects0
Last Updated
March 22, 2016
0Allocation Type
Randomized0
Intervention Model
Crossover Assignment0
Masking Type
Quadruple0
Masked Party
Participant0
Outcomes Assessor0
Investigator0
Care Provider0
Study summary
A Phase 1, randomized, double-blind, placebo-controlled, crossover study to assess the effect of ITCA 650 on the pharmacokinetics (PK) of once daily administration of Levora® (ethinyl estradiol 0.3 mg (EE) and levonorgestrel 0.15 mg (LNG) in healthy premenopausal female subjects.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
