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

Status unconfirmed · Phase 1

Conditions studied: Cumulative Irritation and Sensitization

In brief

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.

Key facts

Study ID

NCT04624867

Run by

Noven Pharmaceuticals, Inc.

People needed

240

Starts

2020-11-03

Expected to finish

2022-01-31

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• QPS Missouri — Springfield, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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