Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol

Inclusion Criteria

• Healthy females of non-child bearing potential, i.e. surgically sterilised or post menopausal subjects. Postmenopausal status will be defined by an absence of menses for a minimum of 12 months and confirmed by a FSH result ≥30 IU/ml
• Negative pregnancy test at screening and Day -1
• 30 to 65 years of age inclusive
• Body mass index between ≥18.0 and ≤30.0 kg/m2
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Must have regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)Must agree to use an adequate method of contraception

Exclusion Criteria

• Participation in a clinical research study within the previous 3 months
• Subjects who are study site employees, or immediate family members of a study site or sponsor employee
• Subjects who have previously been enrolled in this study
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption i.e. >14 units per week (1 unit = ½ pint beer, 25 ml of 40% spirit or a 125 ml glass of wine)
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
• Females who are pregnant or lactating
• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
• Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed at screening
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
• Positive drugs of abuse test result
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• History or presence of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
• Donation or loss of greater than 400 ml of blood within the previous 3 months
• Subjects who are taking, or have taken, any prescribed medications in the 28 days before IMP administration (exceptions may apply on a case by case basis provided they are considered not to interfere with the objectives of the study as agreed by the PI or delegate and sponsor's medical monitor), or over-the-counter drug or herbal remedies in the 14 days before IMP administration. If needed (i.e. an incidental and limited need) ibuprofen is acceptable as analgesic treatment, but must be documented in the (Case Report Form) CRF. Use of paracetamol is forbidden during the entire study
• Subjects who are not in euthyroid condition (thyroid-stimulating hormone [TSH] and free thyroxine [fT4] within the normal reference range)
• Any history of suspected malignancy with the exception of basal cell (excluded if within the prior 2 years) or squamous cell (excluded if within the prior one year) carcinoma of the skin
• History or presence of prolonged QT interval corrected by Bazett's formula or any other clinically significant ECG abnormalities as judged by the investigator based on 12-lead ECG readings at screening
• Subjects with abnormal supine blood pressure at screening: at least 2 readings of systolic blood pressure greater than 140 mmHg or lower than 90 mmHg, and/or diastolic blood pressure of more than 90 mmHg or lower than 50 mmHg after minimum intervals of 5 min
• Any surgical or medical condition which might significantly alter the absorption, distribu