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.

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.

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03556800

Enrollment

Registered

2018-06-14

Start date

2018-05-22

Completion date

2022-06-30

Last updated

2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Hypoestrogenism, Menopausal hormone therapy

Brief 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.

Interventions

DRUGEstrogel

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
To compare the bio-availability of estradiol and estrone.	4 weeks	Blood samples will be analysed.

Secondary

Measure	Time frame	Description
To provide general safety information for VML-0203.	4 weeks	Application site inspections will be assessed.

Countries

United Kingdom

Contacts

Primary ContactDr Simona Fiore, MD

Sfiore@viramal.com020 7495 3052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026