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.

NCT03556800 | Unknown Phase 1

• 1 other identifier: VML-0203-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause

Keywords

Hypoestrogenism; Menopausal hormone therapy

Outcome Measures

Primary Outcomes (1)

• To compare the bio-availability of estradiol and estrone.

  Blood samples will be analysed.

  4 weeks

Secondary Outcomes (1)

• To provide general safety information for VML-0203.

  4 weeks

Study Arms (4)

0.5 gm of EstroCream (VML-0203)

EXPERIMENTAL

Drug: Estrogel

0.75 gm of EstroCream (VML-0203)

EXPERIMENTAL

Drug: Estrogel

1.25 gm of EstroCream (VML-0203)

EXPERIMENTAL

Drug: Estrogel

1.25 EstroGel

ACTIVE COMPARATOR

Drug: Estrogel

Interventions

Estrogel DRUG

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

Also known as: EstroCream

0.5 gm of EstroCream (VML-0203); 0.75 gm of EstroCream (VML-0203); 1.25 EstroGel; 1.25 gm of EstroCream (VML-0203)

Eligibility Criteria

• Age: 30 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viramal Limited: lead
• Simbec Research: collaborator

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

RECRUITING

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Dr Simona Fiore, MD

  Sponsor GmbH

  STUDY DIRECTOR

Central Study Contacts

Dr Simona Fiore, MD

CONTACT

020 7495 3052; Sfiore@viramal.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: May 22, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

GB (1)