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Trial record 24 of 2075 for:    ESTRADIOL

Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

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ClinicalTrials.gov Identifier: NCT03385551
Recruitment Status : Not yet recruiting
First Posted : December 28, 2017
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Palacios

Brief Summary:
This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream

Condition or disease Intervention/treatment
Vulvovaginal Atrophy Drug: Estradiol

Detailed Description:
This is an observational, prospective, open-label, parallel-group study to evaluate the acceptability, efficacy, and preferences of postmenopausal women older than 45 between 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream
Estimated Study Start Date : December 9, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ARM 1
Patients who have been prescribed by the physician within the standard clinical practice 10 micrograms of estradiol vaginal tablets. One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments
Drug: Estradiol
Estradiol or Promestriene depending on the arm
Other Name: Promestriene

ARM 2
Patients who have been prescribed by the physician within the standard clinical practice promestriene 10mg./g vaginal cream. 1 gr. one application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments



Primary Outcome Measures :
  1. Vulvovaginal Symptoms [ Time Frame: Change from Baseline, at week 4 and at week 12 ]
    Dispareunya, dryness, itching nd burning



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal Women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
120 postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation)
Criteria

Inclusion Criteria:

Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period

  • Women who have been prescribed vaginal estradiol tablets or vaginal promestriene cream· Women who have read and signed the Informed Consent Form
  • Women with an intact uterus
  • One or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. Symptoms are moderate if the patient needs a treatment and feels discomfort. Symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities
  • In case of doubt, blood estradiol concentration will be determined, and the subject will only be enrolled if the levels are equal to 30pg./ml. or less.

Exclusion Criteria:

  • Women who had a known or suspected history of breast carcinoma

    • Estrogen dependent neoplasia. Women with a known, past or suscpected Estrogen-dependent malignant tumours such as endormetrial or ovarian cancer
    • Positive or suspicious mammogram results
    • Any systemic malignant disease
    • Hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months Women who had abnormal vaginal bleeding or uterine bleeding of unknown cause
    • Vaginal infection requiring treatment
    • Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) Untreated endometrial hyperplasia Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal Known Hypersensitivity to the active substances or to any of the excipients Porphyria
    • Any serious disease or chronic condition that could interfere with study compliance
    • History of thrombolytic disorders
    • Use of vaginal contraceptives (DIU, vaginal ring…)
    • Participation in another clinical trial in the last three months.

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): NCT03385551


Contacts
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Contact: Santiago Palacios, MD +34 91 578 05 17 investigacion@institutopalacios.com
Contact: Eva Soler, SC +34 91 578 05 17 eva.maria.soler@institutopalacios.com

Locations
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Italy
IRCCS "S Matteo Foundation" Not yet recruiting
Pavia, Italy
Contact: Rosella Nappi, MD       renappi@tin.it   
Contact: Rosella Nappi       renappi@tin.it   
Spain
Instituto Palacios Not yet recruiting
Madrid, Spain, 28009
Contact: Santiago Palacios, MD    915780517    investigacion@institutopalacios.com   
Contact: Eva Soler    915780517    eva.maria.soler@institutopalacios.com   
Principal Investigator: Santiago Palacios, MD         
Sponsors and Collaborators
Instituto Palacios
Investigators
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Principal Investigator: Santiago Palacios, MD Instituto Palacios

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Responsible Party: Instituto Palacios
ClinicalTrials.gov Identifier: NCT03385551     History of Changes
Other Study ID Numbers: IP-AVV2017
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto Palacios:
Vulvovaginal Atrophy
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Atrophy
Pathological Conditions, Anatomical
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female