Study to Investigate the Pharmacokinetics & Safety Following One Application of 3 Different Doses 0.5,0.75,& 1.25 gm,a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGel 1.25 gm to Healthy Post-menopausal Women.
NCT ID: NCT03556800
Last Updated: 2022-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2018-05-22
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
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0.5 gm of EstroCream (VML-0203)
Estrogel
Each subject will receive the following IMPs in accordance with the randomisation code:
* Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
* Reference IMP: a single-dose of 1.25g EstroGel
0.75 gm of EstroCream (VML-0203)
Estrogel
Each subject will receive the following IMPs in accordance with the randomisation code:
* Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
* Reference IMP: a single-dose of 1.25g EstroGel
1.25 gm of EstroCream (VML-0203)
Estrogel
Each subject will receive the following IMPs in accordance with the randomisation code:
* Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
* Reference IMP: a single-dose of 1.25g EstroGel
1.25 EstroGel
Estrogel
Each subject will receive the following IMPs in accordance with the randomisation code:
* Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
* Reference IMP: a single-dose of 1.25g EstroGel
Interventions
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Estrogel
Each subject will receive the following IMPs in accordance with the randomisation code:
* Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
* Reference IMP: a single-dose of 1.25g EstroGel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No menstrual period within the past year before study entry.
* Serum estradiol levels between 0-20 pg/ml.
* FSH levels greater than 25.8 mIU/ml.
* Greater than 45 years of age or if surgical menopausal, \> 30 yrs. of age.
* Have a body mass index (BMI) between 18 and 30 kg/m2. Have had a normal PAP smear test result in line with the following guidelines:
* aged 30 to 49 - within the last 3 years
* aged 50 to 65 - within the last 5 years
Exclusion Criteria
* Has evidence of drug or alcohol abuse.
* Have used hormonal replacement or vaginal hormonal therapy within the past three months before study entry.
* Have used estrogen pellet therapy or progestin injectable drug therapy within the past three months before study entry.
* Has contraindications to HRT use, including: unexplained vaginal bleeding, liver disease, breast or endometrial cancer, venous thromboembolic events.
* Any subjects with an obvious presence of skin conditions, excessive hair at the application sites (no shaving), scar tissue, tattoo, or coloration that would interfere with application of IMP, skin assessment, or reactions to drug.
* Presence of open sores at the application sites.
* Any subjects with a history of significant skin disorder.
* Smoker.
30 Years
FEMALE
Yes
Sponsors
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Simbec Research
INDUSTRY
Viramal Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Simona Fiore, MD
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Simbec Research Ltd
Merthyr Tydfil, Wales, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VML-0203-002
Identifier Type: -
Identifier Source: org_study_id
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