Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch

A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females

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.

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.

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;