MenopausePhase 1NCT03556800
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.
A Phase 1 study testing Estrogel in people with Menopause, run by Viramal Limited at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause
- What is being tested?
- Estrogel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2018to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Presence of open sores at the application sites.
- Any subjects with a history of significant skin disorder.
- Smoker.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Simbec Research Ltd
Merthyr Tydfil, Wales, CF48 4DR
Laura Galligan, +44 (0)1443 694334, laura.galligan@simbec.com
About this study
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.
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.
- Conditions
- Menopause
- Being tested
- Estrogel
- Keywords
- Hypoestrogenism, Menopausal hormone therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogelDrug
Also called EstroCream
Each subject will receive the following IMPs in accordance with the randomisation code:
- Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
- Reference IMP: a single-dose of 1.25g EstroGel
| Study group | Role | What they receive |
|---|---|---|
| 0.5 gm of EstroCream (VML-0203) | Experimental | Not described Receives: Drug: Estrogel |
| 0.75 gm of EstroCream (VML-0203) | Experimental | Not described Receives: Drug: Estrogel |
| 1.25 gm of EstroCream (VML-0203) | Experimental | Not described Receives: Drug: Estrogel |
| 1.25 EstroGel | Active comparator | Not described Receives: Drug: Estrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the bio-availability of estradiol and estrone.
Blood samples will be analysed.
Measured: 4 weeks
Secondary outcomes (1)
To provide general safety information for VML-0203.
Application site inspections will be assessed.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start22 May 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viramal Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Responsible party
- Sponsor
- Investigators
- Dr Simona Fiore, MD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556800
- Sponsor's protocol ID
- VML-0203-002
- Status last verified
- Apr 2022
- First submitted
- 1 Jun 2018
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03556800
- Acronym / sponsor ID
- VML-0203-002
- Conditions
- Menopause
- Keywords
- Hypoestrogenism, Menopausal hormone therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Viramal LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Simbec Research
- Study start
- 22 May 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.5 gm of EstroCream (VML-0203) | Experimental | Drug: Estrogel |
| 0.75 gm of EstroCream (VML-0203) | Experimental | Drug: Estrogel |
| 1.25 gm of EstroCream (VML-0203) | Experimental | Drug: Estrogel |
| 1.25 EstroGel | Active comparator | Drug: Estrogel |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstrogelAlso: EstroCreamEach subject will receive the following IMPs in accordance with the randomisation code: * Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream * Reference IMP: a single-dose of 1.25g EstroGel | Drug | 0.5 gm of EstroCream (VML-0203), 0.75 gm of EstroCream (VML-0203), 1.25 EstroGel, 1.25 gm of EstroCream (VML-0203) |
Primary outcome
To compare the bio-availability of estradiol and estrone.
Time frame: 4 weeks
Blood samples will be analysed.
1 secondary outcome
To provide general safety information for VML-0203.
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Simona Fiore, MD study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Estrogel in people with Menopause, run by Viramal Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Simona Fiore, MD (020 7495 3052, Sfiore@viramal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the bio-availability of estradiol and estrone. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.