A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects

NCT07794150 | Recruiting Phase 1 FDA Drug

• 1 other identifier: P-25-0014
• Study Type: interventional
• Target: 250
• Locations: 2 countries
• Sites: 2

Brief Summary

The two products used in this study are transdermal patches that contain selegiline. The test drug is the Estradiol/Levonorgestrel Transdermal Delivery System (TDS). The comparator drug is the Climara Pro® TDS. The purpose of this research study is to compare how the skin tolerates the test TDS and the comparator TDS. The study will evaluate and compare skin irritation and possible allergic-type skin reactions (sensitization) caused by the two products. The comparison will be based on how the skin responds to repeated applications of each TDS. This includes the assessment of skin irritation during the Induction Period and the evaluation of possible allergic or sensitization reactions after the Challenge Period. In addition, the adhesion of each patch (how well the patch sticks to the skin over time) will be regularly checked, as this is important for both product performance and skin safety.

Conditions

Menopause; Healthy Female Participants

Keywords

Menopause; Healthy female participants

Outcome Measures

Primary Outcomes (2)

• Mean Irritation Score (MIS) for the Test and Reference Patches During the 21-Day Continuous Application Period

  For each participant and patch, an Irritation Score is calculated by adding the Dermal Response Score and the numerical Other Effects Score. The Dermal Response Score ranges from 0 to 7 and the Other Effects Score ranges from 0 to 3, resulting in a combined Irritation Score ranging from 0 to 10; higher scores indicate greater skin irritation. The Mean Irritation Score is calculated separately for the Test Patch and Reference Patch as the sum of the Irritation Scores obtained 30 minutes (+10 minutes) after patch removal on Days 8, 15, and 22, divided by the number of irritation assessments. The baseline assessment is excluded. The primary non-inferiority comparison is based on the difference in overall mean MIS between the Test and Reference Patches (Test minus Reference), using a non-inferiority margin of 0.20.

  From Day 1 through Day 22 (21-day continuous application period; assessments 30 minutes [+10 minutes] after patch removal on Days 8, 15, and 22)

• Number of Participants With a Potential Sensitization Response to the Test or Reference Patch

  Potential sensitization is evaluated separately for the Test Patch and Reference Patch in the Per Protocol Population for Sensitization. A participant is considered to have a potential sensitization response to a patch if the combined Irritation Score (Dermal Response Score plus Other Effects Score) is at least 2 at the participant's last evaluation occurring more than 24 hours after patch removal, such as the 48- or 72-hour evaluation, during the challenge phase and the rechallenge phase if rechallenge is performed.

  At the last evaluation more than 24 hours after challenge patch removal (48 or 72 hours); for rechallenged participants, at the last evaluation more than 24 hours after rechallenge patch removal (48 or 72 hours)

Study Arms (2)

1/2 patch Estradiol/Levonorgestrel TDS on left buttock, 1/2 patch Climara Pro® TDS on right buttock

OTHER

Drug: Estradiol/Levonorgestrel Transdermal System

1/2 patch Estradiol/Levonorgestrel TDS on right buttock, 1/2 patch Climara Pro® TDS on left buttock

OTHER

Drug: Estradiol/Levonorgestrel Transdermal System

Interventions

Estradiol/Levonorgestrel Transdermal System DRUG

1/2 Estradiol/Levonorgestrel Delivery System 0.045 mg per day/ 0.015 mg per day and 1/2 Climara Pro® patch 0.045 mg per day/ 0.015 mg per day will be administered simultaneously

1/2 patch Estradiol/Levonorgestrel TDS on left buttock, 1/2 patch Climara Pro® TDS on right buttock; 1/2 patch Estradiol/Levonorgestrel TDS on right buttock, 1/2 patch Climara Pro® TDS on left buttock

Eligibility Criteria

• Age: 40 Years - 75 Years
• Gender Eligibility Details: The study enrolls only biological females.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Naturally or surgically postmenopausal female, with or without an intact uterus, aged 40-75 years, inclusive. Postmenopausal is defined by FDA Draft Guidance as:
• At least 12 months natural spontaneous amenorrhea; or
• ≥ 6 months and \< 12 months natural spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL at screening; or
• At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
• Any participant who meets criteria a) or c) above and has an FSH level that is considered postmenopausal by national lab standards, is eligible for study enrollment.
• For participants with an intact uterus, has a vaginal ultrasonography and/or MRI (performed at screening or within 3 months before initial patch application) demonstrating inactive endometrial lining with endometrial thickness \< 4 mm.
• A body weight ≤ 90 kg.
• Good health as determined by lack of clinically significant abnormalities in the participant's medical history or health assessments performed at screening (as applicable), as determined by the Investigator (or designee), including a negative mammogram and/or breast MRI (performed at screening or within 9 months before initial patch application), and a normal clinical breast examination.
• Total cholesterol level ≤ 275 mg/dL.
• Triglycerides level ≤ 350 mg/dL.
• For participants at the US clinical site, the participant will be required to read, understand, sign and date the informed consent form, which meets all criteria of current FDA regulations, and must be able to understand the information and instruction given to them during the study.
• For participants at the India clinical site, the participant is able to understand and comply with the study procedures, in the opinion of the Investigator, and able to give voluntary written consent for participation in the study.
• Able and willing to comply with protocol restrictions, required study procedures, and visit requirements.

You may not qualify if:

• Male participants.
• Participants who are premenopausal or perimenopausal, as determined by the Investigator, or pregnant, lactating or likely to become pregnant during the study.
• History of allergy (e.g., anaphylactic reaction), hypersensitivity, or angioedema (including hereditary angioedema) to Climara Pro® or any of its components, including glues/adhesives, or history of any drug hypersensitivity or intolerance that, in the opinion of the Investigator, would compromise the safety of the participant or integrity of the study.
• Presence of any current dermatological condition at the application site(s) (e.g., atopy, psoriasis, eczema, chronic or atopic dermatitis, vitiligo, urticaria) or conditions known to alter skin appearance or physiologic response (e.g., diabetes, porphyria) or history of allergic, sensitization or skin sensitivity that would compromise the integrity of the study data.
• Excessive hair or other compounding factors (e.g., tattoos, scar tissue, recently shaved skin, uneven or obvious difference in skin condition or coloration, sunburn, open sores, moles, body piercings, etc.) at the application sites that, in the opinion of the Investigator, would compromise the ability of the patch to be applied or the ability of the evaluator to observe possible irritation.
• History of or current evidence of hypertension, as determined by the Investigator, or has a seated systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg; determined at screening.
• Significant history or current evidence, as determined by the Investigator, of chronic infectious disease, system disorders, organ dysfunction especially renal disorders, hepatic impairment or disease (especially prior cholestatic jaundice of pregnancy, jaundice with prior estrogen use, or hepatic hemangiomas), gallbladder disease, pancreatitis or hypertriglyceridemia, hypercalcemia, thyroid disorders (especially hypoparathyroidism), residual endometriosis post-hysterectomy, epilepsy, migraine, porphyria, or cardiovascular disorders (especially coronary heart disease).
• Has any risk factors, as determined by the Investigator, for arterial vascular disease/arterial thrombosis (e.g., hypertension, diabetes, tobacco use, or hypercholesterolemia) or venous thromboembolism (VTE) including retinal vascular thrombosis (e.g., personal history or immediate family history of VTE, or systemic lupus erythematosus).
• History or current evidence (i.e., active) of deep venous thrombosis (DVT) or pulmonary embolism (PE), as determined by the Investigator.
• History or current evidence (i.e., active) of arterial thromboembolic disease (e.g., stroke, myocardial infarction, etc.), as determined by the Investigator.
• Known or significant family history (as determined by the Investigator) of coagulation disorders (i.e., bleeding or clotting disorders) such as excessive/prolonged bleeding from cuts, bruising easily, blood clots, etc.
• Known, suspected, significant family history (as determined by the Investigator), or history of breast cancer, bone metastases, endometrial cancer, or ovarian cancer.
• Known or suspected (as determined by the Investigator based on participant's provided medical history) estrogen-dependent neoplasia.
• Known or suspected (as determined by the Investigator based on participant's provided medical history) protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders.
• Undiagnosed persistent or recurring abnormal genital bleeding with unknown etiology.

Sponsors & Collaborators

• Corium Innovations, Inc.: lead

Study Sites (2)

Novum Pharmaceutical Research Services

Las Vegas, Nevada, 89121, United States

RECRUITING

Lambda Therapeutic Research Ltd.

Ahmedabad, Gujarat, 382481, India

NOT YET RECRUITING

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Ann Vollmer

CONTACT

(616) 656-4563; clinicaltrials@coriumintl.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IN (1)