Clinical trial: A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Subjects (NCT02368912)

Eligibility criteria:
Inclusion Criteria:

        Parts 1 & 2:

          -  Healthy young male subject aged 18 to 45 years inclusive

          -  Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.

          -  Male subjects must be non-fertile, or must practice an adequate contraceptive method
             to prevent pregnancies.

        Part 3:

          -  Healthy elderly male subject aged 55 years or older, or healthy pre-menopausal female
             subject aged 18 to 45 inclusive.

          -  Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.

          -  Male subject must be non-fertile, or must practice adequate contraceptive methods.

          -  Female subjects must be of non-child bearing potential, i.e. surgically sterilized or
             practice adequate (double barrier) non-hormonal contraceptive methods.

        Part 4:

          -  Healthy pre-menopausal female subject aged 18 to 45 inclusive.

          -  Body Mass Index more than or equal to 18.5 and less than 30.0 kg/m2.

          -  Female subjects must be of non-child bearing potential, i.e. surgically sterilized or
             practice adequate contraceptive methods.

          -  Females having a regular menstruation cycle with a duration between 25 up to 30 days.

        Exclusion Criteria:

        Parts 1 & 2:

          -  Male subjects with out-of-range Testosterone levels in serum at screening.

          -  Subjects with any history of cancer.

          -  Any of the liver function tests (i.e. ALT and AST) above the upper limit of normal.

          -  A QTc interval of > 430 ms after repeated measurements.

          -  Regular use of any inducer of metabolism (e.g. barbiturates, rifampin) in the 3 months
             prior to admission to the Clinical Unit.

          -  Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

        Part 3:

          -  Pregnancy within 6 months before screening assessment or breast feeding 3 months
             before screening.

          -  Male subjects with out-of-range T levels in serum at screening.

          -  Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.

        Part 4:

          -  Pregnancy within 6 months before screening assessment or breast feeding 3 months
             before screening.

          -  Use of any hormonal interfering contraceptives in the 3 months before admission (for 3
             consecutive menstruation cycles) OR any evidence of unovulatory menstrual cycles.

          -  Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment