Treatment in postmenopausal women with Lenzetto (Estradiol 1.53 mg/actuation transdermal spray).

Phase 4

Conditions: Health Condition 1: Z798- Other long term (current) drug therapy

Registration Number: CTRI/2024/04/066430

Lead Sponsor: Themis Medicare Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Naturally or surgically postmenopausal women (35 years or older) with a history of moderate to severe vasomotor symptoms: adequate washout period from estrogen-containing products prior to baseline assessments if previously treated.

Exclusion Criteria

1. Refusal to sign the informed consent

2. Contraindications for the use of Lenzetto according to the prescribing information (below):

- Known, past or suspected breast cancer;

- Known or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer);

- Undiagnosed genital bleeding;

- Untreated endometrial hyperplasia;

- Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism);

- Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency)

- Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction);

- Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal;

- Porphyria;

- Hypersensitivity to the active substance or to any of the excipients.

Study & Design

Study Type: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To monitor the Local Skin Tolerability; occurrence of all commonly reported AEs including any clinically relevant differences observed in lab parameters, vital signs or physical examination findings: Local Skin Tolerability, Adverse Event Reporting, Lipid Profile, Vital Signs, Physical Examination.Timepoint: Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Name	Time	Method
Assessment of climacteric symptoms/severity by five point Menopause Rating Scale (MRS). <br/ ><br>Mean change in frequency of mild, moderate and severe vasomotor symptoms. <br/ ><br>Mean change in severity of mild, moderate and severe vasomotor symptoms. <br/ ><br>Overall effect of treatment as assessed by the Investigators by using Clinical Global Impression (CGI) seven point rating scale.Timepoint: Baseline, Week 4, Week 8, Week 12