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.

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


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.

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


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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note