Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Randomized Study on Efficacy and Safety of Clino-san® in the Management of Vaginal Dryness in Breast Cancer Patients
Brief Summary: 1. Although after treatment for breast cancer such as chemotherapy or hormonal therapy, urogenital atrophy is common, the patients are seldomly treated for several reasons. Management of this problem is important for improving quality of life.
2. "Clino-san" is a kind of vaginal lubricant with pH 5 which is similar pH of premenopausal vaginal discharge. After randomization of patients, they are treated with Clino-san or placebo 3 times/week for 12 weeks.
3. We check the vaginal symptoms, vag dryness severity score, and ultrasonography at baseline, 4, 8, and 12 weeks of treatment.


Options:
A: 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
B: Inclusion Criteria:

* Cervical cancer (stage I, II, or III) patients who have completed definitive treatment at least 2 months earlier and who were diagnosed between 9 and 20 months prior to enrollment.

Exclusion Criteria:

* Stage IV cervical cancer.
* Have undergone previous treatment with biological response modifier or prior immunotherapy within 4 weeks of study enrollment.
* Used investigational drugs within 30 days.
* Were under immune suppression for any reason.
C: Inclusion Criteria:

* breast cancer patients
* who are treated with chemotherapy or hormonal therapy
* who experience no menstruation after the previous therapy
* who complain of vaginal dryness

Exclusion Criteria:

* other cancer patients
* other severe disease
* poor compliance
D: 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.

Answer: C