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.

Menopause Clinical Trial

Official title:

A Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety Following a Single Application of Three Different Doses 0.5 gm (0.5 mg Estradiol), 0.75 gm (0.75 mg Estradiol) and 1.25 gm (1.25 mg Estradiol), a Transdermal Estradiol Cream (VML-0203), in Comparison to a Single Dose of EstroGelTM 1.25 gm (1 Unit/0.75 mg of Estradiol) to Healthy Post-menopausal Women.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03556800
• Other study ID #: VML-0203-002
• Status: Recruiting
• Phase: Phase 1
• Start date: May 22, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: Viramal Limited
• Contact: Dr Simona Fiore, MD
• Phone: 020 7495 3052
• Email: Sfiore[@]viramal.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety following a Single Application of Three Different Doses 0.5 gm (0.5 mg estradiol), 0.75 gm (0.75 mg estradiol) and 1.25 gm (1.25 mg estradiol), a Transdermal Estradiol Cream (VML-0203), in comparison to a single dose of EstroGelTM 1.25 gm (1 unit/0.75 mg of estradiol) to healthy post-menopausal women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Healthy post-menopausal (surgical or natural) female defined as:

• 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:

• Is pregnant (urine pregnancy test at screening) or lactating.

• 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.

Related Conditions & MeSH terms

• Menopause

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United Kingdom	Simbec Research Ltd	Merthyr Tydfil	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Viramal Limited	Simbec Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the bio-availability of estradiol and estrone.	Blood samples will be analysed.	4 weeks
Secondary	To provide general safety information for VML-0203.	Application site inspections will be assessed.	4 weeks