Phase 3 N=167 Randomized Triple-blind Treatment

Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.

Vaginal Atrophy

Bottom Line

View on ClinicalTrials.gov: NCT04574999 ↗

Enrolled (actual)

167

Serious AEs

0.6%

Results posted

Dec 2020

Primary outcome: Primary: Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment — 26.9; 3.2 vaginal health index — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Estriol (Drug); Placebo (Other)
Age: Pediatric, Adult, Older Adult
Sex: Female
Sponsor: Italfarmaco S.A
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in Maturation Value (MV) After 12 Weeks of Treatment	26.9; 3.2	<0.001 sig
SECONDARY Change From Baseline to Week 12 of the Vaginal pH After the 12-week Observation Period	-1.2; -0.4	<0.001 sig
SECONDARY Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 12-week Observation Period	114; 53; 0; 0; 0; 0	—
SECONDARY Change From Baseline to Week 3 in Maturation Value (MV) After 3 Weeks of Treatment	37.9; 3.6	<0.001 sig
SECONDARY Change From Baseline to Week 3 of the Vaginal pH After the 3-week Observation Period	-1.4; -0.3	<0.001 sig
SECONDARY Number of Participants With Variation of the Individual Signs and Symptoms of Vaginal Atrophy After the 3-week Observation Period	114; 53; 0; 0; 0; 0	—

Summary

Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy. Primary objective: • To evaluate the efficacy of 0.005% Estriol vaginal gel by evaluation of the change in the maturation value of the vaginal epithelium (MV) after 12 weeks of treatment. Secondary objectives: * To determine the variation of the vaginal pH, as well as symptoms and signs suggestive of vaginal atrophy after 12 weeks of treatment. * To study the variation of the MV, pH and symptoms and signs suggestive of vaginal atrophy after an initial observation period of 3 weeks. * To evaluate the safety of 0.005% Estriol vaginal gel * To evaluate the acceptability of 0.005% Estriol vaginal gel

Eligibility Criteria

Main Inclusion Criteria:

Women of any age.
Menopause with amenorrhea time ≥ 2 years, either due to natural or surgical menopause (bilateral oophorectomy).
Presence of symptoms and signs of atrophy of the vaginal mucosa including at minimum vaginal dryness as a symptom stated by the patient, together with at least one sign of the disease verified by the investigator.
As symptoms the patient could state vaginal dryness, pruritus, burning, dyspareunia, dysuria or any other symptom that the investigator considered related to the presence of vaginal atrophy.
As signs the investigator assessed in the gynaecological examination with a speculum, a thinned vaginal mucosa or with flattening of folds, a dry, fragile and pale vaginal mucosa, the presence of petechiae or any other sign that the investigator considered indicative of the existence of vaginal atrophy
Patients with mammography carried out in the period of one year prior to inclusion in the study.
Patients able to understand the nature and purpose of the study, to cooperate with the investigator and meet the study requirements.
Patients who gave written informed consent to participate in the study.

Exclusion Criteria

Patients with contraindications for hormone therapy with estrogens because they had a history of:
Malignant or premalignant lesions of the breasts or endometrium.
Pathology of malignant colon tumour.
Malignant melanoma
Hepatic tumour pathology
Venous thromboembolic conditions (deep vein thrombosis, pulmonary embolism) or arterial thromboembolic conditions (angor pectoris, myocardial infarction, cerebrovascular accident), peripheral arterial disease, mesenteric artery thrombosis, renal artery thrombosis
Coagulopathies
Vaginal bleeding of unknown etiology
Patients who had abnormal laboratory values at the start of the study that the investigator considered clinically relevant for the purposes of the present study.
Patients with signs and symptoms suggestive of infection of the genital or urinary tract at the start of the study.
Patients with any medical-surgical pathology, which was uncontrolled at the time of inclusion in the study.
Patients with any acute process whose handling or evolution the investigator considered could interfere in the development of the study.
Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound.
Patients with grade II or higher uterovaginal prolapse.
Patients who had received any type of vulvovaginal treatment in the 15 days prior to the start of the study.
Patients who had received phytoestrogens in the period of one month prior to the start of the study, including administration by vaginal route.
Patients who had received hormone therapy in the period of 3 months prior to the start of the study, including the administration of estrogens by vaginal route.
Patients on treatment with drugs described in section 7.3 of the protocol
Patients with a history of allergy to any of the components of the medication under study (see the composition in section 3.3. of the protocol).
Patients who had participated in the experimental evaluation of any drug during the 8 weeks before the start of the present study.

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Data sourced from ClinicalTrials.gov (NCT04574999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.