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A Open-Labeled, Non-Controlled Study for Formestane Cream in Healthy Volunteers

A Open-Labeled, Non-Controlled Study for Formestane Cream in Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022068
Enrollment
Unknown
Registered
2019-03-23
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

breast cancer

Interventions

1:Formestane cream

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
48 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1 8 postmenopausal healthy women; 2 BMI between 18.5-32; 3 No medical treatment was received within the past month before the trail (including but not limited to essential oils containing hormones, drugs, etc.).

Exclusion criteria

Exclusion criteria: 1. Blood routine: (a) If WBC, RBC, HB, PLT, N% and L% are significantly abnormal. (b) If the WBC is elevated or lowered, slightly elevated or decreased parameters are acceptable. 2. Urine routine: a number of indicators are significantly abnormal. 3. Blood biochemistry (liver and kidney function)are significantly abnormal: (a) total protein reduction. (b) Liver function (ALT, AST) and elevated creatinine (Crea). (b) Those with abnormal c-reactive protein. 4. ECG: Sinus bradycardia (heart rate < 55 times/min), and other abnormal ECG. 5. Chest x-ray: lung lesions. 6. Ultrasound of breast: BI-RADS-0,2,3,4,5 or 6.

Design outcomes

Secondary

MeasureTime frame
Formestane and its metabolites;

Countries

China

Contacts

Public ContactWu Bin
1843320672@qq.com+86 15282477373

Outcome results

None listed

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