Advertisement

Topics

Proellex Pharmacokinetics Bridging Study

2014-08-27 03:15:55 | BioPortfolio

Summary

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Proellex, Proellex, Proellex, Proellex

Location

Healthcare Discoveries, Inc
San Antonio,
Texas
United States
78209

Status

Completed

Source

Repros Therapeutics Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:55-0400

Clinical Trials [23 Associated Clinical Trials listed on BioPortfolio]

Study to Evaluate Menses Induction in Women Administered Proellex

The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.

A Study Evaluating the Safety of 25 and 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Proellex® Pharmacokinetic Bridging Study II

This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. T...

An Extension Study of 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

To determine the safety of extended treatment with Proellex in women who have successfully completed either study ZPV-201 or ZPU-203 and meet eligibility criteria.

PubMed Articles [4397 Associated PubMed Articles listed on BioPortfolio]

Defining and Estimating Healthy Aging in Spain: A Cross-sectional Study.

Using an operational continuum of healthy aging developed by U.S. researchers, we sought to estimate the prevalence of healthy aging among older Spaniards, inform the development of a definition of he...

Peace, Love, Field Day: An Innovative Approach to Cultivating Healthy Academic Communities.

The American Nurses Association declared 2017 the Year of the Healthy Nurse. In an effort to promote a healthy academic environment, faculty and staff in institutions of higher learning should serve a...

Healthy China 2030, a breakthrough for improving health.

China has the largest population in the world, and its health levels have greatly affected the healthy development of the population of the world. Healthy China 2030 is a breakthrough for ensuring tha...

Ontario's Healthy Babies Healthy Children Screen tool: identifying postpartum families in need of home visiting services in Ottawa, Canada.

Across Ontario, the Healthy Babies Healthy Children (HBHC) postpartum screening tool is routinely used to identify families with potential risk of negative development outcomes for children.

Increased practice of a standing motor sequence task in healthy young and healthy elders: Short communication.

Sequence-specific learning (SSL); the ability to implicitly integrate repeated sequences compared to random sequences during a motor sequence paradigm, is impaired in healthy elders (HE) compared to h...

Medical and Biotech [MESH] Definitions

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.

Process of evaluating the health of a patient and determining if they are healthy enough for surgery.

Dietary patterns which have been found to be important in reducing disease risk.

More From BioPortfolio on "Proellex Pharmacokinetics Bridging Study"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Healthcare
Health care (or healthcare) is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, a...


Searches Linking to this Trial