Overview

Bioequivalence of Two Fixed-dose Combination Tablets Containing Estradiol and Nomegestrol Acetate

Status:
Withdrawn
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
This study will investigate the bioavailability in fasting post-menopausal women of 2 film-coated tablet formulations containing 1.5 milligrams (mg) of estradiol and 2.5 mg of nomegestrol acetate. The study will be performed at a single site. Participants will take a single oral dose of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 21 days between each study period.
Phase:
Phase 1
Details
Lead Sponsor:
Grünenthal GmbH
Collaborators:
Grünenthal S.A.
Grünenthal, S.A.
Treatments:
Estradiol
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Estradiol valerate
Megestrol
Polyestradiol phosphate