Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Use of Low Dose Testosterone To Enhance Libido In Female Cancer Survivors: A Phase III Randomized, Placebo-Controlled, Double-Blind Crossover Study
Brief Summary: RATIONALE: The hormone testosterone may improve the libido (sex drive) in women. It is not yet known whether testosterone is effective in improving libido in female cancer survivors.

PURPOSE: This randomized phase III trial is studying how well low-dose testosterone works to improve libido in postmenopausal cancer survivors.


Options:
A: Eligibility Criteria

1. Women aged 18 to 70 years old.
2. Has a previous diagnosis of breast cancer (ductal or lobular carcinoma, invasive).
3. 1 year from diagnosis of breast cancer.
4. Stable heterosexual partnership =/\>5 years or by investigator discretion.
5. More than 6 months of consistent insertional pain with intercourse (may have stopped having intercourse due to this consistent experience of pain).
6. Menopausal, demonstrated by at least one of the following:

   i. cessation of menses for 1 years ii. Bilateral oophorectomy iii. Follicle Stimulating Hormone (FSH) level \>25 in women below age 50 with an ovary and scarred or absent uterus (acceptable FSH levels can be inferred if the woman's oncologist monitors FSH during aromatase inhibitor therapy).
7. Willingness to enter a study comparing a topical placebo liquid to topical liquid lidocaine.
8. Willingness to evaluate the liquids by use of a tampon test as many as 4 times per month, and willingness to attempt intercourse if the tampon test indicates tolerable penetrative pain.

3.2 Exclusion Criteria

1. Diagnosis of benign or malignant phyllodes tumor of the breast.
2. Consistently has pain in the pelvis or low abdomen during or after intercourse (deep dyspareunia).
3. Has developed shrinkage of the vaginal opening or vaginal length to the point of being too small to succeed in having vaginal penetration with the partner (will also be assessed at the clinical exam).
4. Partner has a problem of sexual dysfunction limiting his performance or making it inconsistent.
5. The potential subject or her partner has a serious current medical condition that might interrupt completion of a 6 month study.
6. Potential subject has been diagnosed by a physical therapist with significant pelvic floor muscle dysfunction causing pain (pelvic floor myalgia).
7. Potential subject has used topical or systemic estrogen within the last 4 months.
8. Has continued tenderness of vestibule mucosa immediately after application of both test liquids.
9. Allergy to lidocaine or other numbing agents.
B: DISEASE CHARACTERISTICS:

* History of cancer

  * No active disease
* Currently has a sexual partner
* Reports a decrease in sexual desire or libido and would like an intervention for it

  * Defined as a score of less than 8 on the numerical analogue scale

PATIENT CHARACTERISTICS:

Age

* See Menopausal status

Sex

* Female

Menopausal status

* Postmenopausal, defined as the following:

  * Surgically induced menopause OR absence of a period for at least 12 months (naturally or treatment-induced)

Performance status

* ECOG 0-1

Hematopoietic

* WBC ≥ 2,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* No untreated anemia

Hepatic

* SGOT ≤ 1.5 times upper limit of normal (ULN)
* No known liver disease

Renal

* Creatinine ≤ 1.5 times ULN
* No renal dysfunction

Cardiovascular

* No coronary artery disease
* No congestive heart failure

Other

* No untreated hypothyroidism
* No diabetes
* No major depressive disorder requiring treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

* Concurrent cytotoxic chemotherapy (e.g., tamoxifen or aromatase inhibitors) allowed

Endocrine therapy

* No prior testosterone
* No prior androgen agents for libido
* Concurrent selective estrogen receptor modulators allowed
* Concurrent vaginal estrogen allowed provided it was initiated ≥ 1 month ago and continued at the same dose during study participation

Radiotherapy

* Concurrent radiotherapy allowed

Surgery

* No prior major pelvic surgery resulting in anatomical changes to the vaginal anatomy

  * Prior hysterectomy allowed

Other

* Concurrent antidepressants for postmenopausal mood or hot flashes allowed provided patient is on a stable dose that will not change within the next 8 weeks
* No concurrent anticoagulants or propanolol

  * Concurrent anticoagulants for central or peripheral line maintenance (e.g., warfarin 1 mg daily or heparin flushes) allowed
* No other concurrent treatment for decreased libido
C: Inclusion Criteria:

* Woman.
* Between 18 and 65 years of age.
* Diagnosis of histologically confirmed primary breast cancer.
* Received treatment in one of the participating hospitals.
* Completed treatment for breast cancer(with the exception of endocrine therapy).
* Diagnosis of breast cancer between 6 months and 5 years prior to study entry.
* Disease-free at time of study entry.
* Presence of sexuality and intimacy problems.

Exclusion Criteria:

* Lacks basic proficiency in Dutch.
* No access to the internet.
* Serious cognitive or psychiatric problems (i.e. depression, alcohol dependency, or psychotic disorders).
* Severe relationship problems for which the internet-based program is not designed (and which need to be addressed prior to undergoing sex therapy).
* Participation in a concurrent therapy program to alleviate sexuality/intimacy problems.
* Treated for another type of cancer beside breast cancer (with the exception of cervical carcinoma in situ and basal cell carcinoma).
D: Inclusion Criteria

* Medically stable, ambulatory, surgically menopausal women, 21-60 years of age, who have undergone bilateral salpingo-oophorectomy and hysterectomy at least 6 months before study entry
* Serum total testosterone concentrations less than 31 ng/dL or free testosterone less than 3.5 pg/ml (less than the median for healthy, young women
* Able to understand and give informed consent.
* The women will have been on a stable regimen of transdermal estrogen replacement for at least three months. Those who are not on estrogen replacement or are taking a different mode of estrogen replacement will be included only if they are willing to switch to transdermal estradiol patch (see below).
* A normal PAP smear (if subject has a cervix) and mammogram in the preceding 12 months.

Exclusion Criteria:

* Significant depression, as assessed by Beck's Depression Scale.
* Any acute or chronic illness, malignant disease or fever of known or unknown origin will be excluded.
* Poorly controlled diabetes mellitus (hemoglobin A1c greater than 8.5%)
* Uncontrolled hypertension defined as blood pressure of greater than 160/100
* Severe obesity defined as body mass index of greater than 40 kg/m2
* Current or recent (last 6 months) users of illicit drugs (which may affect appetite, food intake, metabolism, and/or compliance with the protocol)
* Any one planning to initiate a weight-reduction diet in the subsequent six months
* Alcohol or drug dependence currently or in the preceding 6 month.
* Significant liver function abnormalities, defined as SGOT, SGPT or alkaline phosphatase value of greater than three times the upper limit of normal in our Clinical Pathology Laboratory or serum bilirubin levels of greater than 1.5 mg/dl will be excluded.
* History of breast, ovarian, endometrial or cervical cancer
* History of hyperandrogenic disorders such as hirsutism, grade 2 or 3 acne, and polycystic ovary disease. Testosterone administration to these patients may exacerbate the underlying disorder.
* Intolerance to other transdermal formulations
* Women with abnormal PAP smears or mammograms will not be included unless they have been evaluated by their gynecologists and breast and uterine/cervical cancers have been excluded by appropriate tests.
* Women with dementia as assessed by the mini-mental state examination
* Women with depression, assessed by Beck's Depression Scale.
* Those with disabilities that would prevent them from participating in strength testing (e.g., amputation of limbs, blindness, severe arthritis, neurologic disorders such as Parkinson's disease, stroke, or myopathy).
* Women with any heart disease, including angina, congestive heart failure, or history of myocardial infarction or coronary artery angioplasty or bypass surgery in the previous year will be excluded.
* Subjects planning to initiate a weight-reduction diet in the subsequent six months
* Other Medications. Women who have received in the preceding three months drugs known to affect testosterone production or metabolism such as ketoconazole, Megace, and/or anabolic/androgenic steroids will be excluded. We will also exclude women who are taking or have taken in the past three months medication that include sexual dysfunction (e.g., spironolactone, SSRIs, GnRH agonists). Women who are using any medication, device or dietary supplement known to enhance sexual function will not be included. Women receiving thyroid hormone replacement therapy may participate in the study only if they have been on a stable replacement dose of L-thyroxine for at least three months.
* Intolerance to estrogen products or skin patches
* Undiagnosed vaginal or vulvar bleeding
* History of deep vein thrombosis, pulmonary embolism, or other thromboembolic disorder

Answer: B