Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-Center, Open-Label Study to Assess the Durability and Safety of the Prevention of Bone Loss by Treatment With GL701 (Prestara™) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids
Brief Summary: Open label safety and efficacy follow-up.


Options:
A: INCLUSION CRITERIA

* Women at least 18 years of age.
* Meet ACR criteria for diagnosis of SLE.
* Concomitant treatment with prednisone at a dose of ≥5 mg/day over the last 30 days prior to Screening visit.
* Cumulative history of oral glucocorticoid use for at least 6 months over the last year prior to the Screening Visit (the 6 months do not have to be consecutive).
* Patient has lumbar spine and proximal femur anatomy suitable for measurement by DXA with at least 3 evaluable vertebrae from L1 to L4.
* SLEDAI ≥3 at the Qualifying Visit.
* Women of child-bearing potential must have a negative serum pregnancy test (at the Screening Visit) and agree to use a reliable form of birth control while participating in the study.
* Patient is fully ambulatory.
* Patient has read and signed an Informed Consent Form.

EXCLUSION CRITERIA

* History of breast cancer or malignancy of the reproductive tract organs.
* History of any other cancers unless no evidence of disease for 5 years.
* History of endometrial hyperplasia.
* End stage renal disease or receiving hemodialysis treatment.
* Any disease or condition that would preclude the accurate measurement of bone mineral density of the lumbar spine or proximal femur by dual X-ray absorptiometry.
* A T-score of less than or equal to - 2.5 of the L-spine or proximal femur at Screening DXA assessment.
* Unstable cardiac disease.
* Conditions causing bone loss such as hyperparathyroidism, Cushing's disease, thyrotoxicosis, chronic diarrheal state or malabsorption, renal tubular acidosis, or anorexia nervosa.
* Significant hepatic disease (i.e., cirrhosis).
* Body mass index \> 35 kg/m2 or weight \>300 lbs.
* Patients who are pregnant or breast feeding.
* Patients who require glucocorticoids by an alternate day dosing schedule.
* Known hypersensitivity to DHEA, or the inactive ingredients used in the GL701 formulation (cornstarch, lactose, magnesium stearate).
* Known medical contraindication or hypersensitivity to Calcium/Vitamin D.
* Participation in any prior DHEA or GL701 study.
* Use of investigational agents within 30 days of the Screening Visit or 10 half-lives of the agent.
* Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).
* The patient is taking or has taken one of the medications listed below:

ANTIRESORPTIVES:

* Use of calcitonin within 30 days prior to Screening Visit.
* Fluorides \> 1 mg/day at any time prior to the study.
* Strontium at pharmacologic dose at any time.

BISPHOSPHONATE USE as follows:

* Any use within 90 days prior to the Screening Visit.
* ≥ 2 weeks of use in the last year prior to the Screening Visit.
* ≥ 3 months of use in the last 2 years prior to the Screening Visit.
* ≥ 1 intravenous dose over the last 2 years prior to the Screening Visit.
* ≥ 6 months of life-time exposure prior to the Screening Visit.

ESTROGENIC STEROIDS (Except for oral contraceptives):

* Estrogenic steroids (HRT) within 60 days of the Screening Visit.
* Selective estrogen receptor modulator (raloxifene) within 60 days of the Screening Visit.

OTHER HORMONES:

* Parathyroid hormone (PTH) within six months of the Screening Visit.
* Use of any androgens, including prescription or nutritional supplement DHEA, within 30 days of the Screening Visit.
B: Inclusion Criteria:

* Patient has completed the full 6 month treatment period with study drug in the previous Genelabs' clinical study GL02-01.
* Concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day.
* Patient has read and signed an Informed Consent Form. If the patient is not fluent in English, the Informed Consent must be signed in her native language.

Exclusion Criteria:

* Patient has had a serious study drug related adverse reaction at any time during the previous GL02-01 study.
* Any condition which in the Investigator's or Sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease).

MEDICATIONS PROHIBITED AT ANY TIME DURING THE STUDY

* Calcitonin
* Bisphosphonates
* Fluoride at pharmacologic dose
* Strontium at pharmacologic dose
* Estrogenic steroids (except oral contraceptives)
* Selective Estrogen Receptor Modulator (raloxifene)
* Parathyroid hormone
* Any androgens, including prescription or nutritional supplement DHEA, other than study drug
* Additional Calcium supplements other than those prescribed as part of this study
C: Inclusion Criteria:

* Woman participating in the research will be in the menopausal phase or after it (above a year in postmenopause)aged 65 and below. Man age range will be 18 - 65.

Exclusion Criteria:

* Individuals suffering from a significant systemic illness, hormonal illness, alcoholism, drug abuse, major depression, "Mano/matroagia" or hypogonadism. Additionally, individuals treated with androgens, antidepressant or any other medication which may cause a disorder in sexual desire.
* Man diagnosed as suffering from prostate carcinoma, BHP or will show PSA levels above 2.5 will not be included.
* Woman treated with HRT or suffering from any of the following diseases will not be included: breast carcinoma, ovarian or uterus cancer or with a first grade family history of one of the mentioned.
D: Inclusion Criteria:

* Be a generally healthy surgically menopausal woman (12 months), 20 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy
* Be a generally healthy naturally menopausal woman (2 years since last period), 40 to 70 years of age, not receiving any systemic estrogen or estrogen progestin therapy.
* Be, in their own judgment, in a stable monogamous sexual relationship for at least one year prior to study entry that is perceived to be secure and communicative with the same partner who is sexually functional and physically present at least 50% of the time.
* Answer affirmatively to ALL of the following questions:

  1. Was the patient's sex life before menopause good and satisfying in general?
  2. Since menopause, has a meaningful loss in the level of desire for sex occurred?
  3. Since menopause, has a significant decrease in sexual activity occurred?
  4. Is the current level of desire for or interest in sex bothering or concerning?
  5. Is an increase in the level of interest in or desire for sex and sexual activity desired?

Exclusion Criteria:

* Physical limitations that would interfere with normal sexual function;
* Estrogen use in the last 12 weeks (vaginal estriol or low dose vaginal estradiol accepted)
* Use of any of the following medications:

  * antiandrogen therapy or topical minoxidil (last 5 years),
  * androgen therapy (past 3 months/implantable past 7 months),
  * systemic corticosteroids,
  * selective serotonin reuptake inhibitors (SSRIs),
  * tricyclic anti-depressants,
  * anti-androgens,
  * systemic beta-blockers,
  * anti-adrenergics,
  * spironolactone,
  * apomorphine,
  * phosphodiesterase type 5 (PDE5) inhibitors (e.g., Viagra, tibolone or selective estrogen receptor modulators (SERMs), including tamoxifen (last 12 weeks))
* Be experiencing any chronic or acute life stress relating to any major life change that may significantly interfere with sexual function;
* Have significant psychiatric disorder (including mild depressive disorder - Beck Depression Inventory-II score of \> 14;
* Have current severe dermatological problems or a known suspected hypersensitivity or allergy to any adhesive or any of the constituents of the transdermal testosterone patch
* Have evidence of or history of malignancy (estrogen dependent or any gynecological cancer) within the last 5 years;
* Have diabetes mellitus, active gallbladder disease, unstable thyroid disease, history of cerebrovascular disease, thrombo-embolic disorders, myocardial infarction or angina within the last 5 years or other significant organic disease that would prevent the patient from completing the study, or otherwise affect the outcome of the study.
* Have significant abnormal pretreatment laboratory parameters.

Answer: B