Pharmacokinetic and Pharmacodynamic Study of Cyclofem

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Cyclofem® is a monthly injectable contraceptive containing 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), a long-acting ester of estradiol. The current study will assess the steady-state pharmacokinetics and pharmacodynamics of medroxyprogesterone acetate (MPA) and estradiol (E2) after administration of Cyclofem® and will provide critical information to determine similar bioavailability of Cyclofem to Lunelle in women residing in the United States of America.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited
• Treatments: CycloProvera; Estradiol; Medroxyprogesterone; Medroxyprogesterone Acetate

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.