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

Primary Purpose

Vulvovaginal Atrophy

Status

Completed

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Estradiol 10 MCG Vaginal Tablet [VAGIFEM]

Promestriene Vaginal

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Vaginal dryness, Vaginal soreness, Vaginal irritation, Dyspareunia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 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 .

Exclusion Criteria:

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.

Sites / Locations

Instituto Palacios

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Estradiol 10 micrograms vaginal tablets

Promestriene 10mg./g vaginal cream

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Vulvovaginal Symptoms

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

Secondary Outcome Measures

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

Percentage of women that verify a relief of atrophic vaginitis dryness, dyspareunia, soreness and irritation symptoms in the questionnaires provided at Visit 1 and Visit 2 compared to intensity of those symptoms at screening visit.

Evaluation of changes in ph.

Percentage of women with changes in pH at Visit 1 and Visit 2 compared to Screening Visit. Comparison with the two groups

Evaluation of vaginal maturation index by Pap smear.

Percentage of woman with changes in vaginal maturation index by Pap smear at Visit 2 compared to Screening Pap smear and comparison between groups.

Evaluation of changes in soreness and irritation.

Occurrence of adverse events

Number of adverse events

Evaluation of endometrium thickness using vaginal ultrasound

Percentage of women with changes in endometrium thickness at Visit 2 compared to Screening Visit and comparison between groups

Full Information

NCT ID

NCT04232813

First Posted

January 10, 2020

Last Updated

February 10, 2021

Sponsor

Instituto Palacios

Collaborators

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04232813

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

January 9, 2020 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Instituto Palacios

Collaborators

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vulvovaginal Atrophy

Keywords

Vaginal dryness, Vaginal soreness, Vaginal irritation, Dyspareunia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Estradiol 10 micrograms vaginal tablets

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Promestriene 10mg./g vaginal cream

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Estradiol 10 MCG Vaginal Tablet [VAGIFEM]

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Promestriene Vaginal

Intervention Description

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

Primary Outcome Measure Information:

Title

Vulvovaginal Symptoms

Description

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

Time Frame