Status:
COMPLETED
A Multi-center, Open-label, Randomized, Parallel Group Study to Evaluate Pharmacokinetic Profile, Effects on the Mechanisms of Contraceptive Efficacy and Safety of Two Progestin-only Patches Containing Different Doses of Levonorgestrel (LNG)
Lead Sponsor:
Premier Research
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Contraception
Eligibility:
FEMALE
18-44 years
Phase:
PHASE1
PHASE2
Brief Summary
WHAT IS THE STUDY PRODUCT? The study product is a contraceptive patch, which has the study drug on the patch. The patch is applied directly to the skin and it contains Levonorgestrel (LNG) in a time-r...
Detailed Description
This is a Phase I/II, multi-center, open-label, randomized, parallel group, pharmacokinetic, pharmacodynamic study of the AG1000-6.5 and AG1000-12.5 transdermal contraceptive delivery systems (TCDS) i...
Eligibility Criteria
Inclusion
- 1\. Good general health.
- 2\. Aged 18-44 years, inclusive, at the enrollment visit.
- 3\. Intact uterus with at least one ovary.
- 4\. Pap test within the last 12 months or undergo a Pap test at screening prior to enrollment. If a potential subject states that she has had a Pap test within the last 12 months, then she will need to provide documentation of acceptable test results.
- 5\. Cervical mucus score of \>7, which is based on the modified Insler scoring system during the screening cycle. The cervical mucus is collected by aspiration and the assessment is based on the modified Insler scoring system (the volume and pH of the mucus are not included in the total scoring) yielding a total possible score of 12 (3, 4).
- 6\. Regular menstrual cycles that occur every 28 ± 7 days.
- If subject is postpartum or post-abortal (with abortion in second trimester), she will be required to have two normal menstrual cycles prior to screening.
- If subject had an abortion in the first trimester, she will be required to have at least one menstrual cycle (two menses) prior to screening.
- 7\. Heterosexually abstinent or, if heterosexually active, must have undergone previous tubal sterilization, be in monogamous relationship with a vasectomized partner, or only use male or female condoms (use of condoms that are pre-lubricated with or without spermicide is acceptable) for the entire duration of the study. Use of a spermicide applied separately is not allowed. Cervical caps or diaphragms are not allowed during study participation.
- 8\. In the opinion of the investigator, able to comply with the protocol, willing to record requested information in the daily diary, and live within the study site catchment area or within a reasonable distance from the site.
- 9\. Understand and sign an IRB approved informed consent form prior to screening activities (including fasting blood draw).
- 10\. Willing to refrain from use of skin lotions/creams/gels on area of patch application and not use any vaginal creams, lubricants, gels, or spermicides for 3 days prior to study admission through to the end of the study.
- 11\. Agree not to participate in any other clinical trials during the course of this study.
Exclusion
- Contraindications for enrollment will be the same as those for use of combined hormonal contraceptives as referenced in the World Health Organization (WHO) Medical Eligibility Criteria(MEC category 1 or 2) (1), in addition to contra-indications specific to this clinical trial including:
- 1\. Known hypersensitivity or contraindication to progestins.
- 2\. Known or suspected pregnancy.
- 3\. Prior hysterectomy or bilateral oophorectomy.
- 4\. Prior cervical surgery (LEEP, Cone biopsy, Cryosurgery).
- 5\. A history (within prior 12 months) or drug or alcohol abuse.
- 6\. Undiagnosed abnormal genital bleeding.
- 7\. Undiagnosed vaginal discharge or vaginal lesions or abnormalities. Subjects diagnosed at screening with a Chlamydia or gonococcus infection may not be included in the trial unless they are treated and proof of cure is documented after treatment (i.e. repeat test with negative results). In accordance with PI/medical designee assessment and local standards of practice, women with a history of genital herpes can be included if outbreaks are infrequent. Antiviral prophylactic therapy is permitted.
- 8\. Uncontrolled thyroid disorder.
- 9\. History or presence of dermal hypersensitivity in response to topical application. Specifically any reaction to application of a plastic bandage (Band-Aid), surgical or bandage tape, other skin patches, or adhesives.
- 10\. Any Pap test finding that would require additional workup or treatment during the study interval. HPV testing will not be done at screening for these subjects.
- 11\. Use of an injectable hormonal contraceptive (Depo-Provera®) within the past 10 months.
- 12\. Use of oral contraceptives, contraceptive implants, or other sex steroid hormones within 30 days prior to screening visit.
- 13\. Women who are breastfeeding or within 30 days of discontinuing breast feeding.
- 14\. Women planning to undergo major surgery within four months of study enrollment.
- 15\. Women planning pregnancy within their months of study enrollment.
- 16\. Smoking in women who are ages 18-44 years old that smoke 15 cigarettes or more per day must be evaluated by the PI for inclusion based on risk factors that would increase their risk for CVD and thromboembolism.
- 17\. Current or past deep vein thrombophlebitis or thromboembolic disorders.
- 18\. History of known thrombophilia in a first-degree relative \<45 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk.
- 19\. Cerebrovascular or cardiovascular disease or increased risk for arterial thrombosis.
- 20\. History of retinal vascular lesions, unexplained partial or complete loss of vision.
- 21\. Known or suspected carcinoma of the breast, endometrium, or any other known or suspected progestin-dependent neoplasia.
- 22\. Past history of any other carcinoma (excluding basal cell carcinomas) unless in remission for more than 5 years.
- 23\. Current or past medically diagnosed severe depression, which, in the opinion of the investigator, could be exacerbated by use of a hormonal contraceptive, unless she is stable on antidepressant medication.
- 24\. Headaches with focal neurological symptoms only in women over 35 years old.
- 25\. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use or other benign or malignant liver tumors; active liver disease.
- 26\. Systolic BP \> 140 mm Hg and/or Diastolic blood pressure (BP) \> 90 mm Hg after 5-10 minutes rest.
- 27\. Clinically significant abnormal serum chemistry values according to the Principal Investigator's judgment.
- 28\. Participation in another clinical trial involving an investigational drug or device within last 30 days (prior to screening).
- 29\. Use of liver enzyme inducers within last 90 days (prior to screening) or intention to use liver enzyme inducers during the study (see Appendix 2 Exclusionary Medication List).
- 30\. Known HIV infection.
- 31\. Women at high risk of contracting HIV, e.g. women with multiple sex partners who need to use condoms consistently, injection drug users. Women enrolled in the study, who use condoms to protect against STIs or pregnancy, should be instructed that they can use condoms that are pre-lubricated with spermicide or lubricated, but they cannot use a spermicide applied separately and they should record all condom use in their diaries.
- 32\. Women who use any medications on the Exclusionary Medication List (see Appendix 2) OR used any within the past three months prior to the screening visit.
- 33\. Women with BMI ≥40 kg/m2 are excluded.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01166412
Start Date
December 1 2010
End Date
July 1 2012
Last Update
January 7 2026
Active Locations (6)
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1
University of Colorado - Adv. Repro. Med.
Aurora, Colorado, United States, 80045
2
Columbia University
New York, New York, United States, 10032
3
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267
4
Oregon Health Sciences University
Portland, Oregon, United States, 97239