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.

Viramal

Status and phase: Unknown; Phase 1

Conditions: Menopause

Treatments: Drug: Estrogel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03556800

VML-0203-002

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups

0.5 gm of EstroCream (VML-0203)

Experimental group

Treatment:

Drug: Estrogel

0.75 gm of EstroCream (VML-0203)

Experimental group

Treatment:

Drug: Estrogel

1.25 gm of EstroCream (VML-0203)

Experimental group

Treatment:

Drug: Estrogel

1.25 EstroGel

Active Comparator group

Treatment:

Drug: Estrogel