Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women

Overview

About this study

The purpose of this two-part study is to evaluate the effect of 15 or 20 mg of Estetrol (E4), or placebo, on the severity and frequency of vasomotor symptoms (VMS) (Efficacy Study Part) and the safety of E4 20 mg (Safety Study Part) in postmenopausal women.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Signed and dated written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, after the nature of the trial has been explained according to local regulatory requirement.
  • Females ≥ 40 up to ≤ 65 years of age at randomization.
  • For hysterectomized subjects: 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).
  • For non-hysterectomized subjects: 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 findings. The screening biopsy should have sufficient endometrial tissue for diagnosis. Biopsies without tissue or with insufficient tissue may be repeated once.
  • 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 Safety Study part: at least 1 moderate to severe VMS per week.
  • Body mass index ≥ 18.0 kg/m² to ≤ 38.0 kg/m².
  • A mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening.
  • 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 (value obtained after washout of estrogen/progestin containing drugs; or at least 6 months of spontaneous amenorrhea with serum FSH > 40 mIU /mL and E2 < 20 pg/mL (value obtained after washout of estrogen/progestin containing drugs, see exclusion criteria 18 and 20);
      • or at least 6 weeks postsurgical bilateral oophorectomy;
    • For hysterectomized subjects:
      • serum FSH > 40 mIU/mL and E2 < 20 pg/mL (values obtained after washout of estrogen/progestin containing drug see exclusion criteria 18 and 20); or
      • at least 6 weeks post-surgical bilateral oophorectomy.
  • 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 to Visit 1.
  • Able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
  • Able and willing to complete trial daily diaries and questionnaires.

Exclusion Criteria:

  • 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.
  • 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).
  • Papanicolaou (PAP) test with atypical squamous cells undetermined significance (ASC-US) or higher (low-grade intraepithelial lesion [LSIL], atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesion [HSIL] [ASC-H], HSIL dysplastic or malignant cells) in sub-totally hysterectomized and non-hysterectomized subjects. 
  • Additional Exclusion Criteria may apply.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ekta Kapoor, M.B.B.S.

Contact us for the latest status

Contact information:

Shawn Fokken CCRP

(507) 293-2740

GIMRESEARCHSTUDIES@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available