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

A prospective, non-interventional, Active post marketing surveillance study of Lenzetto (Estradiol 1.53 mg/actuation transdermal spray) in postmenopausal women. - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/04/066430

Enrollment

400

Registered

2024-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Lenzetto (Estradiol 1.53 mg/actuation transdermal spray): Transdermal spray using a metered-dose pump-One, two or three 90 microlitre sprays administered transdermally to the inner fore

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assessment of climacteric symptoms/severity by five point Menopause Rating Scale (MRS). Mean change in frequency of mild, moderate and severe vasomotor symptoms. Mean change in severity of mild, moderate and severe vasomotor symptoms. 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	—

Measure

Time frame

Assessment of climacteric symptoms/severity by five point Menopause Rating Scale (MRS). Mean change in frequency of mild, moderate and severe vasomotor symptoms. Mean change in severity of mild, moderate and severe vasomotor symptoms. 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

—

Countries

India

Contacts

Public ContactDr Balaji More

Mediclin Clinical Research

ravindra.mote@mediclincr.com8888884024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026