MenopausePhase 1NCT07794150
A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects
A Phase 1 study testing Estradiol/Levonorgestrel Transdermal System in people with Menopause and Healthy Female Participants, run by Corium Innovations, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Healthy Female Participants
- What is being tested?
- Estradiol/Levonorgestrel Transdermal System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Aug 2026to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 Postmenopausal is defined by FDA Draft Guidance as: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.
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- 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.
Who cannot join
- 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.
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- Participants with known allergic or immunological disorders (e.g., primary or acquired immunodeficiencies such as human immunodeficiency virus [HIV] positive or AIDS, allergic diseases such as anaphylaxis, asthma or generalized drug reaction, rheumatoid arthritis or systemic lupus erythematosus). Resolved childhood asthma or minor allergic reactions to environmental allergens or foods need not be reason for exclusion.
- 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.
- Has a scheduled surgery of the type associated with an increased risk of thromboembolism or anticipates periods of prolonged immobilization within 6 weeks after completion of the study.
- Contraindication to estrogen therapy or is currently taking thyroid hormone replacement therapy or anticipates use during the study.
- Within 3 weeks of the study start, use of medications or treatments which, in the opinion of the Investigator, could influence or exaggerate responses to the patches or could alter the inflammatory or immune responses.
- Use of pharmacologic agents or products known to significantly induce or inhibit drug-metabolizing enzymes especially inducers of CYP3A4 and inhibitors of CYP3A4 within 30 days before initial patch application or anticipated use during the study.
- Use of any of the following within the noted times before initial patch application or anticipated use during the study:
- Estrogen pellet therapy or progestin injectable drug therapy within 6 months before initial patch application.
- Progestin implants and estrogen alone injectable drug therapy within 3 months before initial patch application.
- Oral estrogen and/or oral or intrauterine progestin therapy within 8 weeks before initial patch application.
- Transdermal estrogen alone or transdermal estrogen/progestin products within 4 weeks before initial patch application.
- Vaginal hormonal products (e.g., rings, creams, gels) within 1 week before initial patch application.
- Use of prescription or over-the-counter (OTC) antihypertensives (e.g., diuretics, ACE inhibitors, angiotensin II receptor blockers, beta-blockers), pressor agents (e.g., midodrine, vasopressin, norepinephrine, epinephrine, phenylephrine, decongestants, NSAIDs like ibuprofen and naproxen), and estrogens (other than the study drug) from the time screening to initial patch application or anticipated use during the study.
- Use of antihistamines or use of topical drugs at application site within 72 hours before the first patch application.
- Use of any cosmetics, moisturizers, powders, and sunscreen or other topical products (e.g., makeup, oil, lotion, creams sprays, powders, etc.) at the patch application sites within 24 hours before the first patch application.
- Receipt of any drug as part of a research study within at least 30 days before initial dosing.
- Any history of narcotic abuse, drug abuse or alcohol addiction.
- Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test results for drugs of abuse or alcohol at screening.
- Positive pregnancy test at screening.
- Use of tobacco- or nicotine-containing products within 30 days before initial patch application or anticipated use during the study.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Novum Pharmaceutical Research Services
Las Vegas, Nevada, 89121
(702) 435-3902, RecruitLV@novumprs.com
India1 site, 1 recruiting
- Not yet recruiting
Lambda Therapeutic Research Ltd.
Ahmedabad, Gujarat, 382481
About this study
Official title: A Multiple-Center Study to Evaluate the Skin Irritation and Sensitization Potential of a Test Estradiol/Levonorgestrel Transdermal Delivery System (Corium TDS)
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.
Read the detailed description
This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Estradiol/Levonorgestrel transdermal system in comparison to Climara Pro® transdermal patch in healthy postmenopausal women. The study will consist of a 5 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.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales specified within FDA Product Specific Guidance.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
- Conditions
- Menopause, Healthy Female Participants
- Being tested
- Estradiol/Levonorgestrel Transdermal System
- Keywords
- Menopause, Healthy female participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol/Levonorgestrel Transdermal SystemDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1/2 patch Estradiol/Levonorgestrel TDS on left buttock, 1/2 patch Climara Pro® TDS on right buttock | Other | Not described Receives: Drug: Estradiol/Levonorgestrel Transdermal System |
| 1/2 patch Estradiol/Levonorgestrel TDS on right buttock, 1/2 patch Climara Pro® TDS on left buttock | Other | Not described Receives: Drug: Estradiol/Levonorgestrel Transdermal System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start10 Aug 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corium Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794150
- Sponsor's protocol ID
- P-25-0014
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Center Study to Evaluate the Skin Irritation and Sensitization Potential of a Test Estradiol/Levonorgestrel Transdermal Delivery System (Corium TDS)
- ClinicalTrials.gov ID
- NCT07794150
- Acronym / sponsor ID
- P-25-0014
- Conditions
- Menopause, Healthy Female Participants
- Keywords
- Menopause, Healthy female participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Corium Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, evaluator-blinded, randomized phase 1 study evaluating skin irritation and skin sensitization of Estradiol/Levonorgestrel transdermal system in comparison to Climara Pro® transdermal patch in healthy postmenopausal women. The study will consist of a 5 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.
Trained study staff will examine the patch application sites at scheduled time points and will score any skin reactions using standardized assessment scales specified within FDA Product Specific Guidance.
Furthermore, the overall safety of the test product will be compared with that of the comparator product by monitoring and recording any adverse events, side effects, or discomfort experienced during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Naturally or surgically postmenopausal female, with or without an intact uterus, aged 40-75 years, inclusive. Postmenopausal is defined by FDA Draft Guidance as:
- 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.
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol/Levonorgestrel Transdermal System1/2 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 | Drug | 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 |
Primary outcome
Mean Irritation Score (MIS) for the Test and Reference Patches During the 21-Day Continuous Application Period
Time frame: 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)
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.
Number of Participants With a Potential Sensitization Response to the Test or Reference Patch
Time frame: 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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Estradiol/Levonorgestrel Transdermal System in people with Menopause and Healthy Female Participants, run by Corium Innovations, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Vollmer ((616) 656-4563, clinicaltrials@coriumintl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Irritation Score (MIS) for the Test and Reference Patches During the 21-Day Continuous Application Period (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.