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

NCT ID: NCT04624867

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2022-01-31

Brief 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.

Detailed Description

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.

Conditions

Cumulative Irritation and Sensitization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HP-1050 patch

HP-1050 and Xulane will be administered simultaneously.

Group Type: EXPERIMENTAL

HP-1050 Patch

Intervention Type: DRUG

Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.

Interventions

HP-1050 Patch

Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.

Intervention Type: DRUG

Eligibility 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Noven Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

QPS Missouri

Springfield, Missouri, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Study Director

Role: CONTACT

ClinicalTrials@noven.com

305 253 5099

Facility Contacts

Study Director

Role: primary

Other Identifiers

HP-1050-US-02

Identifier Type: -

Identifier Source: org_study_id