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Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00380887
First received: September 26, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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Purpose
The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
| Condition | Intervention | Phase |
|---|---|---|
| Postmenopause | Drug: Premarin | Phase 1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective |
| Official Title: | An Open-Label, Single-Dose, Randomized, 4-Period, Partial Crossover Bioequivalence/Bioavailability Study Among Four New Formulations of Premarin 0.45 mg/Medroxyprogesterone Acetate (MPA) 1.5 mg Compared With a Reference Formulation of Premarin/MPA (Prempro) 0.45 mg/1.5 mg in Healthy Postmenopausal Women |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy postmenopausal women aged 35 to 70 years
- Nonsmoker or smoker of less than 10 cigarettes per day
Exclusion Criteria:
- History or presence of clotting disorders
- History or presence of cancer
- Presence of HIV, hepatitis B or hepatitis C
- History of drug or alcohol abuse
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380887
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380887
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
| ClinicalTrials.gov Identifier: | NCT00380887 History of Changes |
| Other Study ID Numbers: |
0713E1-133, 0713E1-135 |
| Study First Received: | September 26, 2006 |
| Last Updated: | September 26, 2006 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
bioavailability bioequivalence marketed product Premarin |
Medroxyprogesterone acetate MPA Postmenopausal vasomotor symptoms |
Additional relevant MeSH terms:
|
Medroxyprogesterone Acetate Medroxyprogesterone Estrogens, Conjugated (USP) Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Male |
Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptives, Oral, Synthetic Contraceptives, Oral Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on June 23, 2017