NCT04624867

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

November 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

October 22, 2020

Last Update Submit

August 31, 2021

Conditions

Cumulative Irritation and Sensitization

Outcome Measures

Primary Outcomes (2)

  • Skin Irritation Evaluation

    To evaluate skin irritation after exposure to HP-1050 compared to XULANE®

    21 days

  • Sensitization Evaluation

    To evaluate skin sensitization after exposure to HP-1050 compared to XULANE®

    48 hours

Study Arms (1)

HP-1050 patch

EXPERIMENTAL

HP-1050 and Xulane will be administered simultaneously.

Drug: HP-1050 Patch

Interventions

HP-1050 PatchDRUG

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

HP-1050 patch

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QPS Missouri

Springfield, Missouri, 65802, United States

RECRUITING

Central Study Contacts

Study Director

CONTACT

305 253 5099ClinicalTrials@noven.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2020

First Posted

November 12, 2020

Study Start

November 3, 2020

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

US(1)