Effect of Non-estrogenic Pollen Extract PCC-100 on Hot Flushes

Inclusion Criteria: * Postmenopausal women, between 50 and 65 years old (extremes included) at the time of signing the informed consent form; * spontaneous amenorrhea for at least 6 consecutive months in combination with a hormonal diagnosis of being postmenopausal (FSH \> 40 mU/ml and E2 \< 20 pg/ml. In subjects using Tamoxifen, only E2 needs to be determined) or spontaneous amenorrhea for at least 12 consecutive months or having had a bilateral oophorectomy at least 6 weeks prior to screening (with or without hysterectomy); * a history of breast cancer, whatever the received treatment, and currently taking aromatase inhibitors or Tamoxifen since at least 4 weeks. This criterion is not applicable to the 100 subjects entering the study without a history of breast cancer; * a minimum of 49 moderate to severe hot flushes or night sweats during 7 consecutive 24-h periods; * a body mass index \[BMI\] between 18.0 and 35.0 kg/m2, inclusive; * proven normal glycaemia and normal thyroid function as evidenced in a recent serum analysis (in the last year) performed by the General Practitioner or gynaecologist; * The subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions. Exclusion Criteria: * Recently, an abnormal cervical Pap smear that requires surgery within 6 months; * acute or chronic thromboembolic disease, liver disease and/or renal impairment; * uncontrolled diabetes mellitus; * uncontrolled hypertension; * un…