Who is sponsoring NCT01436513?

NCT01436513 is sponsored by Pfizer.

What drugs are being tested in NCT01436513?

Interventions in NCT01436513: Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed), Premarin new tablet (fed).

What condition does NCT01436513 study?

NCT01436513 studies Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause.

Is NCT01436513 still recruiting?

NCT01436513 is currently completed. Last updated 14 March 2012.

Last reviewed 2012-03-14 · How we verify

NCT01436513

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 14 March 2012

What this trial tests

Phase 1 trial testing Premarin reference tablet (fasted) in Primary Ovarian Insufficiency in 72 participants. Completed in 1 March 2012.

Timeline

1 October 2011

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	72
Start date	1 October 2011
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	1 location across Japan

Drugs / interventions tested

Premarin reference tablet (fasted) — full drug profile →
Premarin new tablet (fasted) — full drug profile →
Premarin reference tablet (fed) — full drug profile →
Premarin new tablet (fed) — full drug profile →

Conditions studied

Primary Ovarian Insufficiency — all drugs for Primary Ovarian Insufficiency →
Vaginitis — all drugs for Vaginitis →
Metrorrhagia — all drugs for Metrorrhagia →
Menopause — all drugs for Menopause →

Sponsor

Pfizer — full company profile →

Who can join

Adults 45 to 75, female only, with Primary Ovarian Insufficiency or Vaginitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Time frame: Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Time frame: Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Time frame: Day 1 to Day 4

Sponsor's own description

The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Primary Ovarian Insufficiency

Currently open trials in the same condition.

NCT07357701 — Identifying Genome Variants in Non-Obstructive Azoospermia (NOA) or Primary Ovarian Insufficiency (POI) · recruiting
NCT06357442 — Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Dail · recruiting
NCT06167135 — Polycystic Ovary Syndrome, Mitochondrial Dysfunction, Obesity, Insulin Resistance Infertility (POMODORI) Cohort · recruiting
NCT05327283 — Investigation of Copy Number Variations and Genetic Variants in POI · recruiting

Other Pfizer trials

Trials by the same sponsor.

NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01436513 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 14 March 2012

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01436513.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing