Springfield, Missouri 65802

  • Cumulative Irritation and Sensitization

Purpose:

A randomized, evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system (HP-1050) in comparison to XULANE patch in healthy female volunteers.


Study summary:

This is a dual-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers. The study will consist of a 4-week Screening Phase and a Treatment Phase. The Treatment Phase will consist of the following periods: an Induction Period, a Rest Period followed by a Challenge Period and if needed, a Re-Challenge Period.


Criteria:

Inclusion Criteria: - Healthy non-pregnant, non-lactating females 18-35 years of age (inclusive0 and who are candidates for hormonal contraception; - Subjects who have previously used hormonal contraceptives without complications or naïve subjects for whom hormonal contraceptives are not contraindicated in the opinion of the Principal Investigator; - Subjects who are willing to stop using any current contraceptives for the duration of the study; Exclusion Criteria: - Subjects who are currently taking or have taken oral hormonal contraceptives within 30 days prior to the first patch application; - Subjects who are currently using any long-acting hormonal method of contraception or has used them within the past 3 months; - Subjects who have a contraindication for estrogen or norelgestromin, or subjects who have a history of sensitivity to estrogen or norelgestromin or any related derivatives;


NCT ID:

NCT04624867


Primary Contact:

Study Director
Phone: 305 253 5099
Email: ClinicalTrials@noven.com


Backup Contact:

N/A


Location Contact:

Springfield, Missouri 65802
United States

Study Director

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 04, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.