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.

April 26, 2022 updated by: Viramal Limited

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.5 gm of EstroCream (VML-0203)
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
Other Names:
  • EstroCream
Experimental: 0.75 gm of EstroCream (VML-0203)
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
Other Names:
  • EstroCream
Experimental: 1.25 gm of EstroCream (VML-0203)
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
Other Names:
  • EstroCream
Active Comparator: 1.25 EstroGel
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
Other Names:
  • EstroCream

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viramal Limited

Collaborators

Simbec Research

Investigators

  • Study Director: Dr Simona Fiore, MD, Sponsor GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VML-0203-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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