1. Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy 
2. Subject is pregnant or lactating or is attempting or expecting to become pregnant during the study 
3. Women with abnormally high liver enzymes or liver disease. (ALT or AST exceeding 2.0 x ULN AND total bilirubin exceeding 1.5 x ULN at screening and confirmed on repeat). 
4. Received an investigational drug in the 30 days prior to the screening for this study 
5. Women with a history of PCOS 
6. Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study. 
7. Use of oral contraceptives in the preceding 2 weeks. Use of Depo-Provera® in the preceding 10 months. 
8. Has an IUD in place 
9. Women currently using narcotics 
10. Women currently taking spironolactone 
11. Infectious disease screen is positive for HIV or Hepatitis A, B or C. 
12. Clinically significant abnormal findings on screening examination or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study       
    

NCT02141061_exc_T13
Condition
post-menopausal
NCT02141061_exc_T14
Person
woman
NCT02141061_exc_T15
Temporal
six (6) months or more
NCT02141061_exc_T16
Temporal
immediately prior to screening visit
NCT02141061_exc_T17
Condition
menstrual period
NCT02141061_exc_T18
Negation
without
NCT02141061_exc_T19
Procedure
hysterectomy
NCT02141061_exc_T20
Temporal
prior
NCT02141061_exc_T21
Procedure
oophorectomy
NCT02141061_exc_T22
Condition
pregnant
NCT02141061_exc_T23
Condition
lactating
NCT02141061_exc_T26
Person
Women
NCT02141061_exc_T27
Measurement
liver enzymes
NCT02141061_exc_T28
Condition
liver disease
NCT02141061_exc_T29
Value
high
NCT02141061_exc_T30
Measurement
ALT
NCT02141061_exc_T31
Measurement
AST
NCT02141061_exc_T32
Value
exceeding 2.0 x ULN
NCT02141061_exc_T33
Scope
ALT or AST
NCT02141061_exc_T34
Measurement
total bilirubin
NCT02141061_exc_T35
Value
exceeding 1.5 x ULN
NCT02141061_exc_T36
Temporal
at screening
NCT02141061_exc_T37
Reference_point
screening
NCT02141061_exc_T38
Temporal
in the 30 days prior to the screening
NCT02141061_exc_T39
Reference_point
the screening
NCT02141061_exc_T40
Drug
investigational drug
NCT02141061_exc_T41
Person
Women
NCT02141061_exc_T42
Condition
PCOS
NCT02141061_exc_T43
Observation
history
NCT02141061_exc_T44
Drug
testosterone
NCT02141061_exc_T45
Drug
progestin
NCT02141061_exc_T46
Drug
androgen
NCT02141061_exc_T47
Drug
estrogen
NCT02141061_exc_T48
Drug
anabolic steroids
NCT02141061_exc_T49
Drug
DHEA
NCT02141061_exc_T50
Temporal
for at least 2 weeks prior to screening
NCT02141061_exc_T51
Temporal
during the study
NCT02141061_exc_T52
Reference_point
screening
NCT02141061_exc_T53
Drug
hormonal products
NCT02141061_exc_T55
Scope
testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products
NCT02141061_exc_T56
Drug
oral contraceptives
NCT02141061_exc_T57
Temporal
in the preceding 2 weeks
NCT02141061_exc_T58
Drug
Depo-Provera®
NCT02141061_exc_T59
Temporal
in the preceding 10 months
NCT02141061_exc_T60
Device
IUD
NCT02141061_exc_T61
Person
Women
NCT02141061_exc_T62
Drug
narcotics
NCT02141061_exc_T63
Person
Women
NCT02141061_exc_T64
Drug
spironolactone
NCT02141061_exc_T65
Condition
HIV
NCT02141061_exc_T66
Condition
Hepatitis A
NCT02141061_exc_T67
Condition
Hepatitis B
NCT02141061_exc_T68
Condition
Hepatitis C