VULVOVAGINAL ATROPHY
Conditions
Interventions
Trade Name: Vagifem
Product Name: VAGIFEM
Product Code: 72171
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: ESTRADIOL HEMIHYD
Sponsors
Instituto Palacios
Eligibility
Sex/Gender
All
Inclusion 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 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 . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate acceptability of patients with vulvovaginal atrophy between 17B-Estradiol vaginal tablets and promestriene vaginal cream after 12 weeks.;Primary end point(s): Patients with confirmed vulvovaginal atrophy diagnosis and symptoms of dryness, soreness, irritation and/or dyspareunia. 120 postmenopausal women older than 45 years will be selected to participate in the study.;Timepoint(s) of evaluation of this end point: Q3 2020; Secondary Objective: Efficacy: - To evaluate the relief of atrophic vaginitis symptoms using intensity ratings of none, mild, moderate or severe of dryness and dyspareunia. - To evaluate changes in ph. - To evaluate the vaginal maturation index by Pap smear. - To evaluate changes in soreness and irritation. Safety: - Occurrence of adverse events - Evaluation of endometrium thickness using vaginal ultrasound | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): This study wants to evaluate the acceptability and preference of patients with vulvovaginal atrophy between 17B-Estradiol vaginal tablets and promestriene vaginal cream, as well as the efficacy of these treatments for VVA symptoms. During the study, vaginal examination, Vaginal Health Index, Pap smear, vaginal ultrasound and estradiol levels will be checked to verify the efficacy and safety of the treatment. Subjects will complete some questionnaires to check their satisfaction with the treatment and the acceptability.;Timepoint(s) of evaluation of this end point: Q3 2020 | — |
Countries
Spain
Contacts
Public ContactInstituto Palacios
Instituto Palacios
Outcome results
None listed