Recruiting
Phase 1

HP-1050

Sponsor:

Noven Pharmaceuticals, Inc.

Code:

NCT04624867

Conditions

Cumulative Irritation and Sensitization

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

HP-1050 Patch

Study Details

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.

Conditions

Cumulative Irritation and Sensitization

Study ID

NCT04624867

Start date

Nov 3, 2020

Status verified date

Aug, 2021

Completion date

Jan 31, 2022

Anticipated

Primary completion date

Jan 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 35

Healthy Volunteers: Accepted

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;

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: HP-1050 patch

HP-1050 and Xulane will be administered simultaneously.

Interventions

HP-1050 Patch

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

Primary outcome measure

  • Skin Irritation Evaluation [ Time Frame: 21 days ]
  • Sensitization Evaluation [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Study Director

305 253 5099ClinicalTrials@noven.com

Locations

QPS Missouri

Recruiting

Springfield, Missouri, United States, 65802

More Information

Sponsor

Noven Pharmaceuticals, Inc.

Last update posted

Sep 1, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Noven Pharmaceuticals, Inc. on 2021-09-01.