- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01699022
Pharmacokinetic and Pharmacodynamic Study of Cyclofem
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
Virginia
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Norfolk, Virginia, United States, 23507
- Clinical Research Center Norfolk, Virginia 601 Colley Avenue,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between 18 and 45 years of age, inclusive;
- In good health, as evidenced by history and procedures at screening/enrollment visit
- Without any clinically significant systemic disease;
- Not at risk for pregnancy, having undergone surgical sterilization
- Have had regular menstrual cycles (every 21-35 days) for the past two cycles;
- Planning to reside in the area for at least 7 months after enrolling in the study; and
- Willing and able to comply with study procedures
- Have a body mass index (BMI) between 18 and 30 inclusive.
Exclusion Criteria:
Contraindications to the use of Cyclofem® include:
- 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),
- Symptoms of chest pain or shortness of breath,
- Screening visit blood pressure >140/90, (subjects on hypertensive medications, in good blood pressure control will be admitted).
- Past or current thrombophlebitis or thromboembolic disorders,
- Past or current cerebral vascular or coronary artery disease
- History of stroke, myocardial infarction or ischemic heart disease or complicated valvular heart disease
- Diabetes
- Past or current carcinoma of the endometrium cervix or vagina; breast or other known or suspected estrogen-depended neoplasia,
- Headaches with focal neurological symptoms,
- Unexplained abnormal vaginal bleeding,
- 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).
- Known hypersensitivity to any component of Cyclofem®
Have an abnormal Pap smear in the past 12 months defined as:
- Atypical squamous cells of undetermined significance (ASC-US) without a normal repeat Pap smear at least 6 months later;
- 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;
- 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;
- Current use of rifampin, griseofulvin, phenytoin, carbamazepine, barbiturates, or primidone;
- 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);
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Injection Cyclofem
Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials. Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection. |
Injection Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials. Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medroxyprogesterone Acetate (MPA) Concentrations
Time Frame: "Day 1", "Day 29", "Day 57' and 'Day 85"
|
Assessment of mean trough levels of medroxyprogesterone acetate (MPA) on Day 1, Day 29, Day 57 and Day 85
|
"Day 1", "Day 29", "Day 57' and 'Day 85"
|
Medroxyprogesterone Acetate (MPA) Pharmacokinetics
Time Frame: "Day 85"
|
The mean serum concentration-time profile for medroxyprogesterone acetate (MPA) after three consecutive monthly intramuscular administration of Cyclofem (AUC).
Peripheral blood sample for MPA was to be drawn three times a week for PK assessment during the third treatment month (Days 58, 60, 62, 64, 67, 69, 71, 75, 78, and 85) and for Day 85 (28 days post 3rd dose).
|
"Day 85"
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Medroxyprogesterone Acetate (MPA) Pharmacokinetics Cmax
Time Frame: 85 days
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The mean serum concentration-time profile for medroxyprogesterone acetate (MPA) after three consecutive monthly intramuscular administration of Cyclofem
|
85 days
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Medroxyprogesterone Acetate (MPA) Pharmacokinetics Tmax
Time Frame: "Day 85"
|
Mean serum medroxyprogesterone acetate (MPA) concentrations peaked at 4.1 days (range 1 - 21 days) after the third monthly administration of Cyclofem.
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"Day 85"
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Medroxyprogesterone Acetate (MPA) Pharmacokinetics T1/2
Time Frame: "Day 85"
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"Day 85"
|
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Estradiol (E2) Concentrations
Time Frame: "Day 1", "Day 29", "Day 57' and ''Day 85"
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Mean serum estradiol (E2) concentrations on Day 1, Day 29, Day 57 and Day 85
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"Day 1", "Day 29", "Day 57' and ''Day 85"
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Estradiol (E2) Pharmacokinetics.
Time Frame: Day 28
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AUC 0-28, AUC(0-inf).
Peripheral blood sample for E2 was to be drawn three times a week for PK assessment during the third treatment month.
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Day 28
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Tmax
Time Frame: "Day 85"
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Mean serum concentrations of estradiol (E2) peaked by 3.3 days (range 1 - 7 days) following the third monthly injection
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"Day 85"
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T1/2
Time Frame: "Day 85"
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Mean no of days for medroxyprogesterone acetate (MPA) and estradiol (E2)
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"Day 85"
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Number of Participants Who Achieved Ovulation Determined by Serum Progesterone Concentration
Time Frame: Day 134
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Return of ovulation measured by changes in serum progesterone concentration by analysis on Day 18, Day 21 (Control cycle), Day 103, Day 106, Day 131 and Day 134 indicating the number of subjects who achieved ovulation. Outcome measure description indicates what was measure. |
Day 134
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Collaborators and Investigators
Investigators
- Principal Investigator: David F Archer, MD, Director, Conrad Clinical Research Center.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A09-109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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