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An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System

2014-08-27 03:13:03 | BioPortfolio

Summary

The primary objective of the study is to evaluate the efficacy of NEA TDS in the prevention of pregnancy. The secondary objectives are to assess the safety and the tolerability of the product based on adverse events, vaginal bleeding, physical examinations, clinical laboratory parameters and skin tolerability.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Contraception

Intervention

Norethindrone Acetate

Location

Watson Investigational Site
Birmingham
Alabama
United States

Status

Recruiting

Source

Watson Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:03-0400

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PubMed Articles [928 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for contraception.

Methods of contraception in which physical, chemical, or biological means are used to prevent the SPERM from reaching the fertilizable OVUM.

Behavior patterns of those practicing CONTRACEPTION.

Prevention of CONCEPTION by blocking fertility temporarily, or permanently (STERILIZATION, REPRODUCTIVE). Common means of reversible contraception include NATURAL FAMILY PLANNING METHODS; CONTRACEPTIVE AGENTS; or CONTRACEPTIVE DEVICES.

An enzyme that catalyzes the conversion of acetate esters and water to alcohols and acetate. EC 3.1.1.6.

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