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
  • days left to enroll
    4
  • participants needed
    20
  • sponsor
    Viramal Limited
Updated on 18 May 2022
body mass index
follicle stimulating hormone
estradiol
menstrual period
pap smear
smear
mammogram
serum estradiol
Accepts healthy volunteers

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.

Details
Condition Menopause
Treatment Estrogel
Clinical Study IdentifierNCT03556800
SponsorViramal Limited
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy post-menopausal (surgical or natural) female defined as
Serum estradiol levels between 0-20 pg/ml
No menstrual period within the past year before study entry
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
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