A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgestrel TDS in Healthy Postmenopausal Subjects
Eligible age
40–75 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Corium Innovations, Inc.
You may qualify if…
- ✓ 1. Naturally or surgically postmenopausal female, with or without an intact uterus, aged 40-75 years, inclusive. Postmenopausal is defined by FDA Draft Guidance as:
- ✓ 1. At least 12 months natural spontaneous amenorrhea; or
- ✓ 2. ≥ 6 months and \< 12 months natural spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL at screening; or
- ✓ 3. 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.
- ✓ 2. 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.
- ✓ 3. A body weight ≤ 90 kg.
- ✓ 4. 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.
You may not qualify if…
- ✕ 1. Male participants.
- ✕ 2. Participants who are premenopausal or perimenopausal, as determined by the Investigator, or pregnant, lactating or likely to become pregnant during the study.
- ✕ 3. 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.
- ✕ 4. 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.
- ✕ 5. 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.
- ✕ 6. 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.
- ✕ 7. 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.
- ✕ 8. 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).
Where it's recruiting
Las Vegas
Source: ClinicalTrials.gov · NCT07794150 · last updated 2026-09-10