MedDataX Logo

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

NCT ID: NCT00800618

Last Updated: 2010-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

NCT00556075

Endometriosis
TERMINATED PHASE2

Endometriosis Trial: Study of NBI-56418 in Endometriosis

NCT00109512

Endometriosis
COMPLETED PHASE2

Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

NCT00318500

Dysmenorrhea Dyspareunia Endometriosis +1 more
COMPLETED PHASE2

PGL2001 Proof of Concept Study in Symptomatic Endometriosis

NCT01631981

Endometriosis
COMPLETED PHASE2

A Study of HS-10518 in Healthy Female Participants

NCT06118827

Endometriosis
UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-02413873

PF-2413873 active treatment

Group Type EXPERIMENTAL

PF-02413873 100 mg QD

Intervention Type DRUG

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

PF-02413873 1500 mg QD

Intervention Type DRUG

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

PF-02413873 20 mg QD

Intervention Type DRUG

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

PF-02413873 500 mg QD

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

PF-02413873 Placebo

Intervention Type DRUG

PF-0241383 Placebo once daily for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-02413873 100 mg QD

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

Intervention Type DRUG

PF-02413873 1500 mg QD

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

Intervention Type DRUG

PF-02413873 20 mg QD

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

Intervention Type DRUG

PF-02413873 500 mg QD

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

Intervention Type DRUG

PF-02413873 Placebo

PF-0241383 Placebo once daily for 14 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Overland Park, Kansas, United States

Site Status

Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B0461002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Extension to Study on Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain
NCT04372121 TERMINATED PHASE3
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
NCT05560646 COMPLETED PHASE2
PGL5001 Proof of Concept Study in Inflammatory Endometriosis
NCT01630252 COMPLETED PHASE2
Open-Label Extension Study to ZPE-202
NCT01961908 WITHDRAWN PHASE2
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
NCT00882258 COMPLETED PHASE2
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
NCT01156857 COMPLETED PHASE3
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
NCT00958412 TERMINATED PHASE2
Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT03070951 COMPLETED PHASE3
Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women
NCT00110487 COMPLETED PHASE2
The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.
NCT04417972 COMPLETED PHASE1/PHASE2
Efficacy and Safety Study of Elagolix in Women With Endometriosis
NCT00973973 COMPLETED PHASE2
Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
NCT03751124 COMPLETED PHASE3
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
NCT00797225 COMPLETED PHASE2
Evaluation of Safety, Pharmacokinetics, and Efficacy of Proellex Administered Vaginally in Women With Uterine Fibroids
NCT01451424 COMPLETED PHASE2
A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain
NCT01767090 COMPLETED PHASE2
Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation
NCT00999479 WITHDRAWN NA
Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy
NCT04756037 ACTIVE_NOT_RECRUITING PHASE3
A Phase IIa Clinical Study to Assess the Efficacy and Safety of GenSci048 in Patients With Moderate to Severe Endometriosis-Associated Pain
NCT06963177 RECRUITING PHASE2
A Multinational, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy, Safety and Duration of Effect of a Single Administration of Various Doses of Cetrorelix SR in Subjects With Histologically Confirmed Endometriosis
NCT00244452 COMPLETED PHASE2
A Study to Assess the Efficacy and Safety of HMI-115 in Subjects With Endometriosis-Associated Pain
NCT05101317 COMPLETED PHASE2
Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670
NCT01816815 COMPLETED PHASE1
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
NCT02301897 COMPLETED PHASE2
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata
NCT01629563 COMPLETED PHASE3
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
NCT01116440 TERMINATED PHASE2
Mifepristone 2.5, 5, 10 mg Versus Placebo in the Treatment of Endometriosis
NCT02271958 COMPLETED PHASE2/PHASE3