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.

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Viramal Limited
• Collaborator: Simbec Research
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Be a healthy post-menopausal (surgical or natural) female.

• Serum estradiol levels between 0-20 pg/ml.

• FSH levels greater than 25.8 mIU/ml.

• Greater than 45 years of age if surgical menopausal > 30 yrs. of age.

• Have a body mass index (BMI) between 20 and 30 kg/m2.

• Have had a normal PAP smear test result within the last year before the study entry.

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.