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

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Noven Pharmaceuticals, Inc.

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;