Clinical trial NCT03556800: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Menopause
Keywords: Hypoestrogenism
Menopausal hormone therapy
Lead sponsor: Viramal Limited
Sponsor class: INDUSTRY
Collaborators: name: Simbec Research
First posted: 2018-06-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To compare the bio-availability of estradiol and estrone.
timeFrame: 4 weeks
Secondary outcomes:
measure: To provide general safety information for VML-0203.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Ltd
state: Wales
Study officials:
affiliation: Sponsor GmbH
name: Dr Simona Fiore, MD
role: STUDY_DIRECTOR
References: