Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 2076 for:    ESTRADIOL

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03556800
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Simbec Research
Information provided by (Responsible Party):
Viramal Limited

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.

Condition or disease Intervention/treatment Phase
Menopause Drug: Estrogel Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
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.
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Experimental: 0.5 gm of EstroCream (VML-0203) Drug: Estrogel

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
Other Name: EstroCream

Experimental: 0.75 gm of EstroCream (VML-0203) Drug: Estrogel

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
Other Name: EstroCream

Experimental: 1.25 gm of EstroCream (VML-0203) Drug: Estrogel

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
Other Name: EstroCream

Active Comparator: 1.25 EstroGel Drug: Estrogel

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
Other Name: EstroCream




Primary Outcome Measures :
  1. To compare the bio-availability of estradiol and estrone. [ Time Frame: 4 weeks ]
    Blood samples will be analysed.


Secondary Outcome Measures :
  1. To provide general safety information for VML-0203. [ Time Frame: 4 weeks ]
    Application site inspections will be assessed.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556800


Contacts
Layout table for location contacts
Contact: Dr Finn Larsen, MD 020 7495 3052 flarsen@viramal.com

Locations
Layout table for location information
United Kingdom
Simbec Research Ltd Recruiting
Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
Contact: Laura Galligan    +44 (0)1443 694334    laura.galligan@simbec.com   
Sponsors and Collaborators
Viramal Limited
Simbec Research
Investigators
Layout table for investigator information
Study Director: Dr Finn Larsen, MD Sponsor GmbH

Layout table for additonal information
Responsible Party: Viramal Limited
ClinicalTrials.gov Identifier: NCT03556800     History of Changes
Other Study ID Numbers: VML-0203-002
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viramal Limited:
Hypoestrogenism
Menopausal hormone therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female