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Efficacy and safety of Diphereline and Microreline 3.75mg in breast cancer patients

Comparison of efficacy and safety of Diphereline 11.25 mg, Microreline 11.25 mg, and Microreline 3.75mg in premenopausal breast cancer patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201227049847N1
Enrollment
210
Registered
2021-01-09
Start date
2019-04-04
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Breast Cancer. Malignant neoplasm of breast

Interventions

Intervention 1: The first intervention group: Diphereline 11.25 mg, manufactured by Ipsen France, will be given to patients every three months for one year. Intervention 2: The second intervention gro

Sponsors

Homa Pharmed Company
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Positive estrogen and progesterone receptor Premenopausal patients Perimenopausal patients, if they have the same estradiol levels as premenopausal women.

Exclusion criteria

Exclusion criteria: Existence of metastasis History of hysterectomy and oophorectomy

Design outcomes

Secondary

MeasureTime frame
Menopausal symptoms. Timepoint: Before the intervention, three, six, nine and twelve months after the intervention. Method of measurement: Menopause Rating Scale.;Drug side effects. Timepoint: Before the intervention, three, six, nine and twelve months after the intervention. Method of measurement: Drug side effects checklist.

Primary

MeasureTime frame
Changes in Estradiol level over one year. Timepoint: Before the intervention, 3, 6 and 12 months after the intervention. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSafa Najjar Najafi

Iranian academic center for education culture and research

safa3n@yahoo.com+98 21 8887 6869

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 8, 2026