Research Study for Postmenopausal Women Suffering Moderate to Severe Vasomotor Symptoms

Interested in Participating in a Trial for Women Who Experience Hot Flashes and other Vasomotor Symptoms?

This clinical research study is looking at the safety and effectiveness of an investigational medication option for postmenopausal women suffering from moderate to severe hot flashes and other negative symptoms associated with menopause.

Would you like to take part?

As a volunteer in a research study, you’ll receive medical care related to the study from the study doctor, and regular follow up to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the experimental medication being studied will be of benefit to others or not. Study volunteers are an important part of moving medical care forward.

You may qualify to participate in this study if you:

• Are a postmenopausal female, between the ages of 40 to 65 years inclusive
• Have had a hysterectomy: documented hysterectomy must have occurred at least 6 weeks prior to the start of screening. Hysterectomy can be total or subtotal (i.e., cervix was not removed)
• Have not had a hysterectomy: an evaluable endometrial biopsy taken during screening that reveals no abnormal results, i.e., presence of hyperplasia (simple or complex, with or without atypia), presence of carcinoma, and presence of disordered proliferative endometrium findings. The screening biopsy should have sufficient endometrial tissue for diagnosis
• Are seeking treatment for relief of VMS associated with menopause;
  • For the Efficacy Study part: at least 7 moderate to severe bothersome VMS per day or at least 50 moderate to severe bothersome VMS per week in the last 7 consecutive days during the Screening period
  • For the Endometrial and General Safety Study part: at least 1 moderate to severe VMS per week
• Have a Body Mass Index ≥ 18.0 kg/m^2 to ≤ 38.0 kg/m^2
• Complete a mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening
• Meet post-menopausal status defined as any of the following;
  • For non-hysterectomized subjects:
    • at least 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) >40 milli-International unit (mIU)/mL
    • or at least 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL and E2 <20 pg/mL
    • or at least 6 weeks postsurgical bilateral oophorectomy
  • For hysterectomized subjects:
    • serum FSH >40 mIU/mL and E2 <20 pg/mL
    • or at least 6 weeks post-surgical bilateral oophorectomy
• Are in good physical and mental health, in the judgement of the Investigator as based on medical history, physical and gynecological examination and clinical assessments performed prior Visit 1
• Are able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions
• Are able and willing to complete trial daily paper diaries (if applicable) and questionnaires

You may not qualify to participate if you:

• Have a history of malignancy with the exception of basal cell or squamous cell carcinoma of the skin if diagnosed more than 1 year prior to the Screening visit
• Have any clinically significant findings found by the Investigator at the breast examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer (however, simple cysts confirmed by ultrasound are allowed)
• For non-hysterectomized subjects:
  • History or presence of uterine cancer, endometrial hyperplasia, or disordered proliferative endometrium
  • Presence of endometrial polyps
  • Undiagnosed vaginal bleeding or undiagnosed abnormal uterine bleeding
  • Endometrial ablation
  • Any uterine/endometrial abnormality that in the judgment of the investigator contraindicates the use of estrogen and/or progestin therapy. This includes presence or history of adenomyosis or significant myoma
• Have systolic blood pressure (BP) higher than 130 mmHg, diastolic BP higher than 80 mmHg during screening
• Have a history of venous or arterial thromboembolic disease (e.g., superficial or deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, angina pectoris, etc.), or first degree family history of venous thromboembolism
• Have a history of known acquired or congenital coagulopathy or abnormal coagulation factors, including known thrombophilia’s
• Smoke greater than 15 cigarettes per day
• Have a presence or history of gallbladder disease, unless cholecystectomy has been performed
• Have systemic lupus erythematosus
• Have any malabsorption disorders including gastric by-pass surgery
• Have a history of acute liver disease in the preceding 12 months before the start of screening or presence or history of chronic or severe liver disease
• Have chronic or current acute renal impairment
• Receive diagnosis or treatment of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, etc.)

 

There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.