Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT00459134
Eligibility Criteria:
INCLUSION CRITERIA:
Any female cancer survivor who identifies herself as concerned with her sexual quality of life and answering yes to all three of the screening questions.
* Must express interest in sexual activity
* At least 6 months following completion of all cancer therapy. Hormonal therapy and treatment with Herceptin are allowed.
* No evidence of active cancer based on physical exam and/or radiographic images obtained within 3 months of study.
* Absence of any mental, medical or physical disorder know to affect sexual function.
* No participation in another study with an investigational study drug or device during the 30 days prior to start of study drug.
* Lab values must meet the following criteria at study entry: WBC ≥ 2000, Hgb ≥ 10gm/dl, creatinine ≤ 1.5 x ULN, plt ≥ 100,000, T Bili ≤ 1.5
* ECOG performance status must be 0-2.
* Must be able to take oral medication
* Must be 18 years old or older
* Must be minority (non-white) female.
EXCLUSION CRITERIA:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ArginMax.
* Currently taking any blood thinner such as aspirin (one 81mg aspirin, or one baby aspirin per day allowed), Persantine, Heparin, Lovenox, or Coumadin (low dose Coumadin for catheter patency is allowed).
* Patients currently taking Ginkgo Biloba are not allowed on this study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements and/or ability for sexual function.
* Pregnant women are excluded from this study because ArginMax may be an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ArginMax, breastfeeding should be discontinued if the mother is treated with ArginMax.
* Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ArginMax. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
* Any planned surgery during study participation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00459134
Study Brief:
Protocol Section:
NCT00459134