Clinical trial: Pharmacokinetic and Pharmacodynamic Study of Cyclofem (NCT01699022)

Eligibility criteria:
Inclusion Criteria:

          1. Between 18 and 45 years of age, inclusive;

          2. In good health, as evidenced by history and procedures at screening/enrollment visit

          3. Without any clinically significant systemic disease;

          4. Not at risk for pregnancy, having undergone surgical sterilization

          5. Have had regular menstrual cycles (every 21-35 days) for the past two cycles;

          6. Planning to reside in the area for at least 7 months after enrolling in the study; and

          7. Willing and able to comply with study procedures

          8. Have a body mass index (BMI) between 18 and 30 inclusive.

        Exclusion Criteria:

          1. Contraindications to the use of Cyclofem® include:

               1. Smoking any number of cigarettes per day in a woman > 35 years old (or in a woman
                  34 years-old who will turn 35 years-old during the study),

               2. Symptoms of chest pain or shortness of breath,

               3. Screening visit blood pressure >140/90, (subjects on hypertensive medications, in
                  good blood pressure control will be admitted).

               4. Past or current thrombophlebitis or thromboembolic disorders,

               5. Past or current cerebral vascular or coronary artery disease

               6. History of stroke, myocardial infarction or ischemic heart disease or complicated
                  valvular heart disease

               7. Diabetes

               8. Past or current carcinoma of the endometrium cervix or vagina; breast or other
                  known or suspected estrogen-depended neoplasia,

               9. Headaches with focal neurological symptoms,

              10. Unexplained abnormal vaginal bleeding,

              11. Liver dysfunction or disease, such as a history of hepatic adenoma or carcinoma;
                  history of cholestatic jaundice of pregnancy or jaundice with prior hormonal
                  contraceptive use including severe pruritus of pregnancy, severe cirrhosis, or
                  active hepatitis (defined as aspartate aminotransferase [AST or SGOT ≥ 120 IU/L]
                  or alanine aminotransferase [ALT or SGPT ≥ 135 IU/L]) or clinically significant
                  laboratory abnormalities as judged by the physician evaluating the individual
                  subject).

          2. Known hypersensitivity to any component of Cyclofem®

          3. Have an abnormal Pap smear in the past 12 months defined as:

               1. Atypical squamous cells of undetermined significance (ASC-US) without a normal
                  repeat Pap smear at least 6 months later;

               2. Atypical squamous cells of undetermined significance (ASC-US) with positive
                  reflex high-risk human papillomavirus (HPV) testing (Atypical squamous cells of
                  undetermined significance [ASC-US]/human papillomavirus [HPV]+) or low-grade
                  squamous intraepithelial lesion (LSIL) except when a colposcopy was performed
                  (with or without biopsy) and found no evidence of high-grade disease (cervical
                  intraepithelial neoplasia [CIN II] or worse) unless treatment is indicated per
                  local standard of care;

               3. ASC-H, atypical glandular cells, or high grade squamous intraepithelial lesion
                  (HSIL) unless treatment was received and follow-up at least 6 months after the
                  treatment showed no evidence of disease; malignant cells;

          4. Current use of rifampin, griseofulvin, phenytoin, carbamazepine, barbiturates, or
             primidone;

          5. Other conditions that, in the opinion of the investigator, would constitute
             contraindications to participation in the study or would compromise ability to comply
             with the study protocol, such as any major chronic illness including cancer, serious
             autoimmune disease or a major psychiatric disorder (e.g. schizophrenia);

          6. Current participation in any other drug or device study, or any study which, in the
             opinion of the investigator, would jeopardize interpretation of results of this study;

          7. Active thyroid disease as measured by thyroid-stimulating hormone [TSH] levels ≤0.3
             mU/L or ≥ 5 mU/L. Subjects with thyroid disease in good control with thyroid
             medication will be admitted.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? 1