MedTrace Logo

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

NCT03749733 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-07-15

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Estradiol 1.5 mg/nomegestrol acetate 2.5 mg (Reference Product)

Marketed Drug

DRUG

Estradiol 1.5 mg/nomegestrol acetate 2.5 mg (Test Product)

Investigational Medicinal Product

Sponsors & Collaborators

  • Grünenthal, S.A.

    collaborator INDUSTRY

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03749733 on ClinicalTrials.gov