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.
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.
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.
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.
Single group
Estradiol/Levonorgestrel Transdermal System
Drug1/2 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
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.
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.
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