HealthyPhase 1NCT00649896
Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara® Transdermal System 0.025 mg/Day
A Phase 1 study testing Mylan Estradiol Transdermal System 0.025 mg/day and Climara® Transdermal System 0.025 mg/day in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mylan Estradiol Transdermal System 0.025 mg/day and Climara® Transdermal System 0.025 mg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Sep 2003
- 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 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 40-69 years.
- Sex: Females only.
- Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOAVAILABILITY PROTOCOLS).
- Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
- Baseline FSH and 17-beta-estradiol serum levels consistent with postmenopausal status confirmed within 14 days of initiation of study medication. (FSH greater than or equal to 40 mIU/mL; 17-beta-estradiol less than or equal to 31 pg/mL)
- All subjects should be judged normal and healthy during a prestudy medical evaluation (physical examination, laboratory evaluation and 12-lead ECG) performed within 14 days of the initial patch application.
- The physical examination shall include pelvic and breast exams.
- Pelvic findings should be consistent with hypoestrogenemia. b. A mammogram will be required if not performed within the last 12 months. c. A Papanicolaou ("Pap") smear will be required on subjects with an intact uterus and cervix if not performed within the last 6 months.
Who cannot join
- Institutionalized subjects will not be used.
- Social Habits:
- Use of any tobacco products. b. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
- Ingestion of any vitamins within the 48 hours prior to the initial dose of study medication.
- Any recent, significant change in dietary or exercise habits.
- Medications:
Show all 16Show fewer
- Use of any medication within 14 days prior to the initial dose of study medication.
- Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
- Use of any systemic antibiotics, estrogens, or hormones within 28 days prior to the initial dose of study medication.
- Diseases:
- History of any significant chronic disease such as (but not limited to):
- 1. Thrombotic disorders. 2. Coronary artery or cerebrovascular disease. 3. Liver, kidney or gallbladder dysfunction/disorder(s). 4. Fibrocystic disease or breast nodules. 5. Family history of breast cancer. 6. Diabetes or any other endocrinological disease. 7. Estrogen-dependent neoplasia. 8. Postmenopausal uterine bleeding. 9. Endometrial hyperplasia. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the prestudy medical evaluation or dosing.
- 5. Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II: ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing. 6. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- 7. Allergy or hypersensitivity to tapes or adhesives (ex. Band-aids, medical tape), estradiol or other hormonal products.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of the Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System (0.025 mg/Day; Mylan) and Climara® Transdermal System (0.025 mg/Day; Berlex) in Healthy Postmenopausal Female Volunteers
The primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.
- Conditions
- Healthy
- Being tested
- Mylan Estradiol Transdermal System 0.025 mg/day, Climara® Transdermal System 0.025 mg/day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mylan Estradiol Transdermal System 0.025 mg/dayDrug
Climara® Transdermal System 0.025 mg/dayDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mylan Estradiol Transdermal System 0.025 mg/day Receives: Drug: Mylan Estradiol Transdermal System 0.025 mg/day |
| 2 | Active comparator | Climara® Transdermal System 0.025 mg/day Receives: Drug: Climara® Transdermal System 0.025 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal Safety
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startAug 2003
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence A Galitz, M.D., Principal investigator, SFBC International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649896
- Sponsor's protocol ID
- ESTR-0334
- Status last verified
- Mar 2008
- First submitted
- 30 Mar 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of the Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System (0.025 mg/Day; Mylan) and Climara® Transdermal System (0.025 mg/Day; Berlex) in Healthy Postmenopausal Female Volunteers
- ClinicalTrials.gov ID
- NCT00649896
- Acronym / sponsor ID
- ESTR-0334
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 1 Apr 2008 (estimated)
- 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 primary objective of this study was to compare the adhesive quality of a new formulation of the Mylan Estradiol Transdermal System with that of Climara® Transdermal System following a single system application in 80 healthy postmenopausal female volunteers. As a secondary objective, primary dermal irritation was assessed after removal of each transdermal system.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Mylan Estradiol Transdermal System 0.025 mg/dayMylan Estradiol Transdermal System 0.025 mg/day |
| 2 | Active comparator | Drug: Climara® Transdermal System 0.025 mg/dayClimara® Transdermal System 0.025 mg/day |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 40-69 years.
- Sex: Females only.
- Weight: At least 52 kg (115 lbs) and within 30% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN BIOAVAILABILITY PROTOCOLS).
- Absence of menses for one year for postmenopausal subjects, or at least 6 weeks for oophorectomized subjects. (For oophorectomized subjects, an operative report documenting bilateral oophorectomy and surgical pathology report documenting the absence of malignant disease.)
- Baseline FSH and 17-beta-estradiol serum levels consistent with postmenopausal status confirmed within 14 days of initiation of study medication. (FSH greater than or equal to 40 mIU/mL; 17-beta-estradiol less than or equal to 31 pg/mL)
Key exclusion criteria (16 listed)
- Institutionalized subjects will not be used.
- Social Habits:
- Medications:
- Diseases:
- 1. Thrombotic disorders. 2. Coronary artery or cerebrovascular disease. 3. Liver, kidney or gallbladder dysfunction/disorder(s). 4. Fibrocystic disease or breast nodules. 5. Family history of breast cancer. 6. Diabetes or any other endocrinological disease. 7. Estrogen-dependent neoplasia. 8. Postmenopausal uterine bleeding. 9. Endometrial hyperplasia. b. History of drug and/or alcohol abuse. c. Acute illness at the time of either the prestudy medical evaluation or dosing.
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 |
|---|---|---|
| Mylan Estradiol Transdermal System 0.025 mg/day | Drug | 1 |
| Climara® Transdermal System 0.025 mg/day | Drug | 2 |
Primary outcome
Dermal Safety
Time frame: within 30 days
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 1 Apr 2008.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
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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.
Lawrence A Galitz, M.D. principal investigator
SFBC International
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 Mylan Estradiol Transdermal System 0.025 mg/day and Climara® Transdermal System 0.025 mg/day in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
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 8 inclusion and 16 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 1 Apr 2008. 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 United States. 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?
Dermal Safety (time frame: within 30 days). 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 1 Apr 2008; AzTrials last refreshed its copy on 8 Nov 2026.