at ICON PLC
Posted on Sep. 26, 2016
Postmenopausal Females 2104-0024
San Antonio - Texas
***PLEASE NOTE***: You must live within a 105 mile radius (1.5 hour drive) of San Antonio in order to participate in this study. This is due to certain restrictions in the protocol.
ICON Early Phase Services is conducting a research study for females who are healthy, postmenopausal and between the ages of 50 – 75. This study is being done to test two different dosing methods of an FDA-approved drug. The study drug will be administered by manual injection and an auto-injector.
Vital signs, ECGs, physical examinations, and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
1 screening visit
11 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after a 4- hour fast. You may need to provide medical records to participate in this study. For more information, see below.
Qualified participants may be compensated up to $3,000 for time and travel.
If you are able to answer “YES” to the following statements, you may qualify for this study.
I am a healthy female adult, meaning no significant medical conditions
I am between 50 and 75 years old
I am not taking any estrogen/progesterone hormone replacement therapy
I am not using any estrogen, progestin, or selective estrogen receptor modulator (SERM) treatments. (NOTE: There are various washout time periods for different products.)
I do not smoke or use any tobacco products and I have not used nicotine products within 30 days of the start of the study
I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility
I have not received an investigational study drug in a clinical trial within 30 days of 1st dose for this study
I am not pregnant or breastfeeding
I am not capable of becoming pregnant. I have been postmenopausal for at least 1 year, or, I have been surgically sterile for at least 6 weeks (hysterectomy, ovaries removed with/without the uterus removed). Documentation may be required.
I do not have a significant history or current evidence of chronic infectious disease, system disorder, or organ dysfunction such as cardiovascular (such as heart attack, uncontrolled hypertension,) kidney or liver disorders or other medical conditions (e.g., poorly controlled diabetes or asthma, epilepsy, migraines)
I do not have a history of allergy or sensitivity to hydroxyprogesterone caproate or caster oil
I do not have a history or current evidence of deep vein thrombosis, pulmonary embolism or arterial thromboembolic disease (e.g., stroke or heart attack)
I do not have a known, suspected or current history of breast cancer. No past history of breast cancer on aromatase inhibitors
I do not have a known, suspected or current history of hormone dependent tumor within the last 5 years
I do not have a current or recent (last 12 months) genital bleeding of unknown cause
I do not have a history of psychiatric disorders that required hospitalization within the last 2 years
I have not used any prescription or over-the-counter medication that is knows to alter CYP3A4 or CYP3A5 (e.g., carbamazepine, St. John’s Wort, ketoconazole, rifampin, ritonavir, alprazolam, azithromycin, loratadine, etc.) within 14 days of 1st dose for this study
I do not have a history of treatment for drug or alcohol addiction requiring treatment in the past 12 months
I do not have a history of excessive alcohol consumption (defined as an average of 14+ units of alcohol/week) during the past 12 months
I have not donated or had a significant loss of blood within the last 30 days
I have not donated plasma within 14 days of 1st dose
I do not have a history of any severe or life-threatening allergies (e.g., food or drugs or latex)
I have not had problems having blood drawn in either arm, venous access or finger pricks.
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Frequently, subjects do not qualify because of medical history or minor changes in vital signs, ECG and lab tests. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
To determine if you fully qualify, it will be necessary to obtain blood samples after a 4- hour fast. You will need to refrain from eating or drinking anything (with the exception of water) for 4 hours before your appointment. Please bring all of your medications with you to your screening appointment.
You might feel lethargic, tired or mildly dizzy from fasting. You have the option to come in fasting or return for a second screening to complete lab tests.
We will be testing for alcohol and drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment. You have the option of obtaining a urine sample at the screening appointment or you may return at a later date to obtain urine for an alcohol and drug sample.
Please note, you need to bring a valid, non-expired photo ID and your Social Security Card with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, or passport. Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records.