Who is sponsoring NCT00381251?

NCT00381251 is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

What drugs are being tested in NCT00381251?

Interventions in NCT00381251: Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg.

What condition does NCT00381251 study?

NCT00381251 studies Postmenopausal Osteoporosis, Postmenopause.

Is NCT00381251 still recruiting?

NCT00381251 is currently completed. Last updated 8 June 2007.

Last reviewed 2007-06-08 · How we verify

NCT00381251

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

An Open-Label, Single-Dose, Randomized, 3-Period, Crossover, Bioequivalence Study Between Two New Formulations of 0.45 mg/1.5 mg Premarin / Medroxyprogesterone Acetate (MPA) Compared With a Reference Formulation of 0.45mg/1.5mg Premarin / MPA (Prempro™) in Healthy Postmenopausal Women.

Completed Phase 1 Last updated 8 June 2007

What this trial tests

Phase 1 trial testing Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg in Postmenopausal Osteoporosis. Completed in 1 January 2007.

Timeline

1 September 2006

1 January 2007

Quick facts

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	prevention
Start date	1 September 2006
Estimated completion	1 January 2007

Drugs / interventions tested

Formulations A and B of Premarin/MPA 0.45 mg/0.5 mg and PREMPRO0.45 mg/0.5 mg — full drug profile →

Conditions studied

Postmenopausal Osteoporosis — all drugs for Postmenopausal Osteoporosis →
Postmenopause — all drugs for Postmenopause →

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

Adults 35 to 70, female only, with Postmenopausal Osteoporosis or Postmenopause. Healthy volunteers can join.

What's being measured

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

Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.

Sponsor's own description

This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™. Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in 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:

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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 NCT00381251 (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 Wyeth is now a wholly owned subsidiary of Pfizer
Last refreshed: 8 June 2007

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/NCT00381251.

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