NCT01436513

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

September 16, 2011

Last Update Submit

March 14, 2012

Conditions

Primary Ovarian InsufficiencyVaginitisMetrorrhagiaMenopause

Keywords

bioequivalencemenometrorrhagiaclimacteric disturbanceEstrogen Replacement TherapyEstrogens Conjugated

Outcome Measures

Primary Outcomes (4)

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax

    Day 1 to Day 4

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall

    Day 1 to Day 4

  • Plasma unconjugated equilin pharmacokinetic parameter:Cmax

    Day 1 to Day 4

  • Plasma unconjugated equilin pharmacokinetic parameter:AUCall

    Day 1 to Day 4

Secondary Outcomes (16)

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax

    Day 1 to Day 4

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast

    Day 1 to Day 4

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf

    Day 1 to Day 4

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:MRT

    Day 1 to Day 4

  • Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:half-life

    Day 1 to Day 4

  • +11 more secondary outcomes

Study Arms (4)

A

EXPERIMENTAL

Premarin reference tablet as a single oral dose under fasted conditions

Drug: Premarin reference tablet (fasted)

B

EXPERIMENTAL

Premarin new tablet as a single oral dose under fasted conditions

Drug: Premarin new tablet (fasted)

C

EXPERIMENTAL

Premarin reference tablet as a single oral dose under fed conditions

Drug: Premarin reference tablet (fed)

D

EXPERIMENTAL

Premarin new tablet as a single oral dose under fed conditions

Drug: Premarin new tablet (fed)

Interventions

Premarin reference tablet (fasted)DRUG

Premarin reference tablet, single dose, fasted conditions

A
Premarin new tablet (fasted)DRUG

Premarin new tablet, single dose, fasted conditions

B
Premarin reference tablet (fed)DRUG

Premarin reference tablet, single dose, fed conditions

C
Premarin new tablet (fed)DRUG

Premarin new tablet, single dose, fed conditions

D

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese healthy postmenopausal women

You may not qualify if:

  • History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies.
  • History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malignancy, except for basal or squamous cell carcinoma of skin, which has been treated and fully resolved for a minimal 5 years.
  • History or presence of benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Shinjyuku-ku, Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Primary Ovarian InsufficiencyVaginitisMetrorrhagia

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesVaginal DiseasesUterine HemorrhageUterine DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2011

First Posted

September 19, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

JP(1)