Healthy Female ParticipantsPhase 1NCT07851649
A Study to Assess the Bioavailability and Adhesion of Estradiol/Levonorgestrel TDS in Healthy Post-Menopausal Female Participants
A Phase 1 study testing Test Estradiol/Levonorgestrel Transdermal Delivery System and Climara Pro® (Estradiol/Levonorgestrel Transdermal System) in people with Healthy Female Participants and Postmenopause, run by Corium Innovations, Inc. at 1 site in India.
Trial summary
The purpose of this study is to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), following a single 7-day application in healthy postmenopausal female… Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Participants, Postmenopause
- What is being tested?
- Test Estradiol/Levonorgestrel Transdermal Delivery System and Climara Pro® (Estradiol/Levonorgestrel Transdermal System)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2026to 29 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 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 45-65 years, living in and around Ahmedabad city or western part of India. 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 Postmenopausal is defined by FDA Draft Guidance as: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.
- Only participants that meet one of the above criteria and have their postmenopausal status confirmed by a serum FSH level > 40 mIU/mL are eligible for study enrollment.
- Serum FSH level > 40 mIU/mL; determined at screening.
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- For participants with an intact uterus, has a vaginal ultrasonography demonstrating inactive endometrial lining with endometrial thickness < 4 mm.
- A body weight ≤ 90 kg. Page 36 of 59
- Seated vital signs measurements, determined at screening, as specified below (inclusive): Temperature (T) 96.5-99.4°F, Respiration Rate (RR) 12-20 breaths per minute, Pulse Rate (PR) 50-100 beats per minute, Blood Pressure (BP) 90-140 (systolic)/60-90 (diastolic) mmHg
- Total cholesterol level ≤ 275 mg/dL.
- Triglycerides level ≤ 350 mg/dL.
- 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 screening mammogram and/or Breast MRI and a normal clinical breast examination.
- 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 and required study procedures and visit requirements.
- Serum estradiol level should be clinically acceptable.
- Serum pregnancy test must be negative.
Who cannot join
- Male Participant.
- 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.
- 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 prior to patch application of period-I.
- Use of medications or treatments which, in the opinion of the Investigator, could influence or adhesion/responses to the patches or could alter the inflammatory or immune responses within 3 weeks of the study start.
- 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 of period-I.
- 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 of period-I.
- Progestin implants and estrogen alone injectable drug therapy within 3 months before initial patch application of period-I.
- Oral estrogen and/or oral or intrauterine progestin therapy within 8 weeks before initial patch application of period-I.
- Transdermal estrogen alone or transdermal estrogen/progestin products within 4 weeks before initial patch application of period-I.
- Vaginal hormonal products (e.g., rings, creams, gels) within 1 week before initial patch application of period-I.
- 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 of period-I.
- Any vaccine (including COVID-19 vaccine) within 14 days prior to patch application of period-I.
- Use of antihistamines or use of topical drugs at application site within 72 hours prior to patch application of period-I.
- Use of any cosmetics, moisturizers, powders, and sunscreen or other topical products (e.g., make-up, oil, lotion, creams sprays, powders, etc.) at the patch application sites within 24 hours prior to patch application of period-I.
- Use of tobacco- or nicotine-containing products within 30 days before initial patch application of period-I.
- Previous participation in this study.
- Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- A recent history of harmful use of alcohol (less than 2 years), i.e. alcohol consumption of more than 7 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to patch application of period I.
- History or presence of seizure or psychiatric disorders
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first patch application of study medication or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first patch application of study medication**.
- If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of investigational medicinal product received.
- Note: If a participant had participated in a study in which the total blood loss was ≤ 200 mL, the participant may be dosed 60 days after the last sample of the previous study.
- Consumption of grapefruit or grapefruit products within 72 hours prior to patch application of period-I.
- History or presence of smoking.
- An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to patch application period-I. In any such case participant selection will be at the discretion of the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Compare the Bioequivalence and Adhesion Between a Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg Per Day/0.015 mg Per Day) (Corium TDS) and Reference Climara Pro® at the Same Strength (0.045 mg Per Day / 0.015 mg Per Day) for Seven Days in Post-menopausal Female Participants
The purpose of this study is to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), following a single 7-day application in healthy postmenopausal female participants. The study will also evaluate the safety and tolerability of the test and reference patches.
Read the detailed description
This is an open-label, balanced, randomized, two-treatment, two-period, two-sequence crossover study designed to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), in healthy postmenopausal female participants.
Approximately 68 healthy, non-tobacco- and non-nicotine-using postmenopausal female participants will be randomized to one of two treatment sequences. Participants will receive a single application of the test product in one study period and a single application of the reference product in the other study period, according to the assigned randomization sequence. Each patch will be applied for 168 hours (7 days), and the two treatment periods will be separated by a washout interval of at least 21 days between application days.
Serial blood samples will be collected following patch application to characterize plasma concentrations of estradiol and levonorgestrel and to evaluate bioequivalence between the test and reference products. Patch adhesion will be assessed at prespecified time points throughout the 7-day wear period using a standardized adhesion scoring system. Skin irritation assessments will be performed before application and following patch removal according to protocol-defined procedures.
Safety and tolerability will be evaluated throughout the study through monitoring of adverse events, concomitant medications, clinical laboratory assessments, vital signs, physical examinations, and other protocol-specified safety evaluations.
The study is intended to evaluate whether the pharmacokinetic performance and adhesion characteristics of the test estradiol/levonorgestrel transdermal delivery system are comparable to those of the reference product following a single application in healthy postmenopausal female participants.
- Conditions
- Healthy Female Participants, Postmenopause
- Being tested
- Test Estradiol/Levonorgestrel Transdermal Delivery System, Climara Pro® (Estradiol/Levonorgestrel Transdermal System)
- Keywords
- Healthy female participants, Postmenopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Estradiol/Levonorgestrel Transdermal Delivery SystemDrug
Investigational estradiol/levonorgestrel transdermal delivery system containing estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day. A single patch is applied to the upper quadrant of the buttock and worn continuously for 168 hours (7 days).
Climara Pro® (Estradiol/Levonorgestrel Transdermal System)Drug
Reference-listed estradiol/levonorgestrel transdermal system (Climara Pro®) containing estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day. A single patch is applied to the upper quadrant of the buttock and worn continuously for 168 hours (7 days).
| Study group | Role | What they receive |
|---|---|---|
| Sequence TR (Test → Reference) | Experimental | Participants receive a single application of the Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 1, followed by a washout interval of at least 21 days between application days, and then receive a single application of the Reference Estradiol/Levonorgestrel Transdermal System (Climara Pro®; 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 2. Each patch is applied for 168 hours (7 days). Receives: Drug: Test Estradiol/Levonorgestrel Transdermal Delivery System; Drug: Climara Pro® (Estradiol/Levonorgestrel Transdermal System) |
| Sequence RT (Reference → Test) | Experimental | Participants receive a single application of the Reference Estradiol/Levonorgestrel Transdermal System (Climara Pro®; 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 1, followed by a washout interval of at least 21 days between application days, and then receive a single application of the Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 2. Each patch is applied for 168 hours (7 days). Receives: Drug: Test Estradiol/Levonorgestrel Transdermal Delivery System; Drug: Climara Pro® (Estradiol/Levonorgestrel Transdermal System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Baseline-Corrected Estradiol
Maximum observed plasma concentration (Cmax) of baseline-corrected estradiol following application of the test and reference transdermal delivery systems.
Measured: Predose through 288 hours after patch application
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Baseline-Corrected Estradiol
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) for baseline-corrected estradiol
Measured: Predose through 288 hours after patch application
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Baseline-Corrected Estradiol
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) for baseline-corrected estradiol.
Measured: Predose through 288 hours after patch application
Maximum Plasma Concentration (Cmax) of Levonorgestrel
Maximum observed plasma concentration (Cmax) of levonorgestrel following application of the test and reference transdermal delivery systems.
Measured: Predose through 288 hours after patch application
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Levonorgestrel
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) for levonorgestrel.
Measured: Predose through 288 hours after patch application
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Levonorgestrel
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) for levonorgestrel.
Measured: Predose through 288 hours after patch application
Mean Adhesion Score (MAS)
Mean adhesion score during the 168-hour patch wear period, assessed using the protocol-defined FDA adhesion scoring scale.
Measured: Immediately after patch application through 168 hours after patch application
Secondary outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Incidence of treatment-emergent adverse events following administration of the test and reference transdermal systems.
Measured: From first patch application through 21 days after the last patch application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Jul 2026
- Primary completion29 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female ParticipantsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corium Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niraj Vasisht, Study director, Corium Innovations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851649
- Sponsor's protocol ID
- P-25-0013
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare the Bioequivalence and Adhesion Between a Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg Per Day/0.015 mg Per Day) (Corium TDS) and Reference Climara Pro® at the Same Strength (0.045 mg Per Day / 0.015 mg Per Day) for Seven Days in Post-menopausal Female Participants
- ClinicalTrials.gov ID
- NCT07851649
- Acronym / sponsor ID
- P-25-0013
- Conditions
- Healthy Female Participants, Postmenopause
- Keywords
- Healthy female participants, Postmenopause
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Corium Innovations, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 29 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 1 Oct 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 purpose of this study is to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), following a single 7-day application in healthy postmenopausal female participants. The study will also evaluate the safety and tolerability of the test and reference patches.
Detailed description
This is an open-label, balanced, randomized, two-treatment, two-period, two-sequence crossover study designed to compare the bioequivalence and adhesion performance of a test estradiol/levonorgestrel transdermal delivery system (TDS) with the reference product, Climara Pro® (estradiol/levonorgestrel transdermal system), in healthy postmenopausal female participants.
Approximately 68 healthy, non-tobacco- and non-nicotine-using postmenopausal female participants will be randomized to one of two treatment sequences. Participants will receive a single application of the test product in one study period and a single application of the reference product in the other study period, according to the assigned randomization sequence. Each patch will be applied for 168 hours (7 days), and the two treatment periods will be separated by a washout interval of at least 21 days between application days.
Serial blood samples will be collected following patch application to characterize plasma concentrations of estradiol and levonorgestrel and to evaluate bioequivalence between the test and reference products. Patch adhesion will be assessed at prespecified time points throughout the 7-day wear period using a standardized adhesion scoring system. Skin irritation assessments will be performed before application and following patch removal according to protocol-defined procedures.
Safety and tolerability will be evaluated throughout the study through monitoring of adverse events, concomitant medications, clinical laboratory assessments, vital signs, physical examinations, and other protocol-specified safety evaluations.
The study is intended to evaluate whether the pharmacokinetic performance and adhesion characteristics of the test estradiol/levonorgestrel transdermal delivery system are comparable to those of the reference product following a single application in healthy postmenopausal female participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence TR (Test → Reference) | Experimental | Drug: Test Estradiol/Levonorgestrel Transdermal Delivery System, Drug: Climara Pro® (Estradiol/Levonorgestrel Transdermal System)Participants receive a single application of the Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 1, followed by a washout interval of at least 21 days between application days, and then receive a single application of the Reference Estradiol/Levonorgestrel Transdermal System (Climara Pro®; 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 2. Each patch is applied for 168 hours (7 days). |
| Sequence RT (Reference → Test) | Experimental | Drug: Test Estradiol/Levonorgestrel Transdermal Delivery System, Drug: Climara Pro® (Estradiol/Levonorgestrel Transdermal System)Participants receive a single application of the Reference Estradiol/Levonorgestrel Transdermal System (Climara Pro®; 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 1, followed by a washout interval of at least 21 days between application days, and then receive a single application of the Test Estradiol/Levonorgestrel Transdermal Delivery System (0.045 mg/day estradiol and 0.015 mg/day levonorgestrel) during Period 2. Each patch is applied for 168 hours (7 days). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Naturally or surgically postmenopausal female, with or without an intact uterus, aged 45-65 years, living in and around Ahmedabad city or western part of India. inclusive. Postmenopausal is defined by FDA Draft Guidance as:
- Only participants that meet one of the above criteria and have their postmenopausal status confirmed by a serum FSH level > 40 mIU/mL are eligible for study enrollment.
- Serum FSH level > 40 mIU/mL; determined at screening.
- For participants with an intact uterus, has a vaginal ultrasonography demonstrating inactive endometrial lining with endometrial thickness < 4 mm.
- A body weight ≤ 90 kg. Page 36 of 59
Key exclusion criteria (42 listed)
- Male Participant.
- 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.
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 |
|---|---|---|
| Test Estradiol/Levonorgestrel Transdermal Delivery SystemInvestigational estradiol/levonorgestrel transdermal delivery system containing estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day. A single patch is applied to the upper quadrant of the buttock and worn continuously for 168 hours (7 days). | Drug | Sequence RT (Reference → Test), Sequence TR (Test → Reference) |
| Climara Pro® (Estradiol/Levonorgestrel Transdermal System)Reference-listed estradiol/levonorgestrel transdermal system (Climara Pro®) containing estradiol 0.045 mg/day and levonorgestrel 0.015 mg/day. A single patch is applied to the upper quadrant of the buttock and worn continuously for 168 hours (7 days). | Drug | Sequence RT (Reference → Test), Sequence TR (Test → Reference) |
Primary outcome
Maximum Plasma Concentration (Cmax) of Baseline-Corrected Estradiol
Time frame: Predose through 288 hours after patch application
Maximum observed plasma concentration (Cmax) of baseline-corrected estradiol following application of the test and reference transdermal delivery systems.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Baseline-Corrected Estradiol
Time frame: Predose through 288 hours after patch application
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) for baseline-corrected estradiol
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Baseline-Corrected Estradiol
Time frame: Predose through 288 hours after patch application
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) for baseline-corrected estradiol.
Maximum Plasma Concentration (Cmax) of Levonorgestrel
Time frame: Predose through 288 hours after patch application
Maximum observed plasma concentration (Cmax) of levonorgestrel following application of the test and reference transdermal delivery systems.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Levonorgestrel
Time frame: Predose through 288 hours after patch application
Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t) for levonorgestrel.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Levonorgestrel
Time frame: Predose through 288 hours after patch application
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-inf) for levonorgestrel.
Mean Adhesion Score (MAS)
Time frame: Immediately after patch application through 168 hours after patch application
Mean adhesion score during the 168-hour patch wear period, assessed using the protocol-defined FDA adhesion scoring scale.
1 secondary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first patch application through 21 days after the last patch application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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. This study is not recruiting at the moment.
Niraj Vasisht study director
Corium Innovations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Test Estradiol/Levonorgestrel Transdermal Delivery System and Climara Pro® (Estradiol/Levonorgestrel Transdermal System) in people with Healthy Female Participants and Postmenopause, run by Corium Innovations, Inc. at 1 site in India.
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 16 inclusion and 42 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: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of Baseline-Corrected Estradiol (time frame: Predose through 288 hours after patch application). The study lists 7 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 3 Nov 2026.