Clinical trial: Females, Aging, Metabolism, and Exercise (NCT01712230)

Eligibility criteria:
Inclusion Criteria:

          1. Healthy women aged 40 to 60 years

          2. Are still experiencing regular menstrual cycles.

          3. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks

          4. Be physically able to be randomized to participate in a programmed exercise training
             program.

        The investigators will consent up to 132 subjects with the aim of enrolling 22 in each of
        the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise).

        Exclusion Criteria:

          -  irregular menstrual cycles defined as 2 or more missed cycles in the previous year

          -  serum FSH >25 mIU/mL measured during the first 5 days of the menstrual cycle

          -  on hormonal contraceptive or menopausal therapy

          -  positive pregnancy test

          -  intention to become pregnant or start hormonal contraceptive therapy during the period
             of study

          -  lactation

          -  known hypersensitivity to GnRH or leuprolide acetate

          -  score >16 on the CESD((Center for Epidemiologic Studies Depression Scale )

          -  severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores <
             -2.0)

          -  abnormal vaginal bleeding

          -  thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers
             with abnormal TSH values will be re-considered for participation in the study after
             follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone
             replacement

          -  uncontrolled hypertension defined as resting systolic BP >150 mmHg or diastolic BP>90
             mmHg; participants who do not meet these criteria at first screening will be
             re-evaluated, including after follow-up evaluation by the PCP with initiation or
             adjustment of anti-hypertensive medications

          -  cardiovascular disease; subjective or objective indicators of ischemic heart disease
             (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the
             graded exercise test (GXT) without follow-up evaluation; follow-up evaluation must
             include diagnostic testing (e.g., thallium stress test) with interpretation by a
             cardiologist

          -  orthopedic or other problems that would interfere with participation in the exercise
             program

          -  exercising at least 30 minutes per day at a moderate to vigorous intensity most days
             of the week (defined as >4 d/wk) over the past 6 months

          -  BMI <40 kg/m2
Female
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
Subject must be at most 60 Years

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