Impact of tissue specific isoflavone profiles on the formation, activation, and action of 17ß-estradiol in the female mammary gland

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000598

Enrollment

100

Registered

2010-11-23

Start date

2012-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

estradiol homeostasis and associated effects in breast tissue

Interventions

Group 1: Supplement: commercially avialable isoflavone-rich soy extract (Novasoy) Dose: 1 - 1,3 mg isoflavone (genistein + daidzein, aglyca + glycoside)/kg body weight/day. Application: Prior to surge

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: cosmetically motivated breast reduction surgery

Exclusion criteria

Exclusion criteria: Pathological changes in the breast tissue, family history of breast cancer, soy allergy

Design outcomes

Primary

Measure	Time frame
Endpoint: biotransformation of estradiol and isoflavonen in the mammary gland. Time point: 1 day after last application. Method: GC- and LC/MS/MS.	—

Secondary

Measure	Time frame
Endpoints: cellular response zu altered estradiol biotransformation (genotoxicity, cell proliferation and differentiation in the mammary gland). Time point: 1 day after the las application. Method: real-time PCR, immunohistology.	—

Countries

Germany

Contacts

Public ContactIva Neskova

Universitätsklinikum WürzburgChirurgie II

neshkova_i@ukw.de0931-20137028

Outcome results

None listed

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