Completed PHASE1 INTERVENTIONAL 4-arm NCT01436513

A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.

Phase 1, Open-Label, Randomized, Single-Dose, Crossover Bioequivalence And Food Effect Study For A New Formulation Of Premarin Compared With A Reference Tablet In Japanese Healthy Postmenopausal Women

Sponsor: Pfizer

Conditions Menopause Metrorrhagia Primary Ovarian Insufficiency Vaginitis

Interventions Premarin new tablet (fasted) Premarin new tablet (fed) Premarin reference tablet (fasted) Premarin reference tablet (fed)

Updated 5 times since 2017 Last updated: Mar 14, 2012 Started: Oct 31, 2011 Primary completion: Mar 31, 2012 Completion: Mar 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01436513, this PHASE1 trial focuses on Menopause and Metrorrhagia and remains completed. Sponsored by Pfizer, it has been updated 5 times since 2011, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Oct 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Pfizer

Data source: Pfizer

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Shinjyuku-ku, Japan