Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

NCT04232813 | Completed Phase 3

• 1 other identifier: IP-AVV2019
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the Acceptability and Efficacy of 10 Micrograms of Estradiol Vaginal Tablets vs Promestriene Vaginal Cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).

Conditions

Vulvovaginal Atrophy

Keywords

Vaginal dryness; Vaginal soreness; Vaginal irritation; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• Vulvovaginal Symptoms

  Percentage of patients with vulvovaginal atrophy that accept 17B-Estradiol vaginal tablets vs promestriene vaginal cream after 12 weeks

  Change from Baseline, at week 4 and at week 12

Secondary Outcomes (6)

• Evaluation of relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia.

  Change from Baseline, at week 4 and at week 12

• Evaluation of changes in ph.

  Change from Baseline, at week 4 and at week 12

• Evaluation of vaginal maturation index by Pap smear.

  Change from Baseline, at week 4 and at week 12

• Evaluation of changes in soreness and irritation.

  Change from Baseline, at week 4 and at week 12

• Occurrence of adverse events

  Change from Baseline, at week 4 and at week 12

Study Arms (2)

Estradiol 10 micrograms vaginal tablets

ACTIVE COMPARATOR

One tablet intravaginally once daily for two weeks. Thereafter one tablet twice per week with at least a 3-days interval between treatments to maintain therapeutic response.

Drug: Estradiol 10 MCG Vaginal Tablet [VAGIFEM]

Promestriene 10mg./g vaginal cream

ACTIVE COMPARATOR

One application once daily intravaginally for two weeks. Thereafter one application twice per week with at least a 3-days interval between treatments to maintain therapeutic response.

Drug: Promestriene Vaginal

Interventions

Estradiol 10 MCG Vaginal Tablet [VAGIFEM] DRUG

To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.

Estradiol 10 micrograms vaginal tablets

Promestriene Vaginal DRUG

To insert the cream the patient must use the applicator provided in the way explained in the prospectus.

Promestriene 10mg./g vaginal cream

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period
• 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.
• Blood estradiol concentration of 30 pg/ml or less .

You may not qualify if:

• Women who have not signed the Informed consent Form
• Women who had a known or suspected history of breast carcinoma
• Estrogen dependent neoplasia. Women with a known, past or suspected Estrogen-dependent malignant tumours such as endometrial 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.

Sponsors & Collaborators

• Instituto Palacios: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Instituto Palacios

Madrid, 28009, Spain

Location

Related Publications (1)

• Palacios S, Ramirez M, Lilue M. Efficacy of low-dose vaginal 17beta-estradiol versus vaginal promestriene for vulvovaginal atrophy. Climacteric. 2022 Aug;25(4):383-387. doi: 10.1080/13697137.2021.1998436. Epub 2021 Nov 23.

  PMID: 34813408 DERIVED

MeSH Terms

Conditions

Dyspareunia

Interventions

Estradiol; Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Prospective, monocentric, open-label, randomized, parallel-group study.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: January 9, 2020
• Primary Completion: June 30, 2020
• Study Completion: November 30, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)