A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women

A Double Blind (3rd Party Open), Randomised, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration, Pharmacology And Pharmacokinetics, Of Multiple Doses Of PF-02413873 In Healthy Female Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00800618

Enrollment

Registered

2008-12-02

Start date

2008-11-30

Completion date

2009-06-30

Last updated

2010-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women

Interventions

DRUGPF-02413873 1500 mg QD

1500 mg of PF-02413873 oral suspension once daily for 14 days

DRUGPF-02413873 100 mg QD

100 mg of PF-02413873 oral suspension once daily for 14 days

DRUGPF-02413873 20 mg QD

20 mg of PF-02413873 oral suspension once daily for 14 days

DRUGPF-02413873 500 mg QD

500 mg of PF-02413873 oral suspension once daily for 14 days

DRUGPF-02413873 Placebo

PF-0241383 Placebo once daily for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy women of childbearing potential with a regular menstrual cycle

Exclusion criteria

* Evidence or history of any major disease * Pregnant or nursing women * Requirement for chronic medication

Design outcomes

Primary

Measure	Time frame
Adverse events, vital signs measurements, 12-lead ECGs, physical examination findings, blood safety tests.	1 month
PF-02413873 pharmacokinetics	1 month
Endometrial thickness, Ovarian follicular estradiol secretion, Pre-ovulatory LH surge, Corpus Luteum progesterone secretion.	14 days

Countries

Belgium, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026