Clinical trial NCT03566290 (phase 2, status: terminated)
Conditions: stress urinary incontinence
ICD codes: N39.41, N39.46, N39.490, N39.491, N39.492, R32, R39.81
Drugs: gtx-024
SMILES: C[C@](O)(COC1=CC=C(C=C1)C#N)C(O)=NC1=CC(=C(C=C1)C#N)C(F)(F)F
Reason stopped: 
    lack of efficacy
  
Eligibility criteria:

        Inclusion Criteria:

          -  Be an eligible subject from G201002, where an eligible subject is defined as:

               1. one of the first 225 subjects who were randomly assigned to the placebo group in
                  G201002 and who have completed the required treatment and durability periods of
                  that study, or;

               2. any subject from 226 onwards, who was randomly assigned to any treatment group
                  and who completed the required treatment and follow-up periods of that study

          -  Be able to read, understand, and provide written, dated, informed consent prior to
             enrollment in the current study and be likely to comply with the study protocol and
             communicate with study personnel about AEs and other clinically important information

          -  Provide written consent to participate in the study within the following timeframes:

               1. for G201002 Subjects 1-225, within 30 days after unblinding of G201002 (subjects
                  who consent to participate in G201003 will be allowed to discontinue from that
                  study and consent to this study upon unblinding of G201002)

               2. for G201002 Subjects 226-493, within 30 days of completing both the treatment and
                  follow-up periods of G201002

          -  Agree to maintain a stable dose of any medication known to affect lower urinary tract
             function, including but not limited to anticholinergics, tricyclic antidepressants,
             beta-3 adrenergic agonists, or α-adrenergic blockers, throughout the duration of the
             study

        Exclusion Criteria:

          -  Starts any new treatment (medication, pelvic floor physical therapy, or other
             treatment known to impact the pelvic floor) after completing G201002 that is known or
             suspected to affect lower urinary tract function, including vaginal rejuvenation

          -  Subject is currently taking systemic sex-hormone products (excludes intravaginal
             application of estradiol topical/tablet agents and hormones delivered via vaginal
             rings)

          -  Has a current cancer diagnosis (with the exception of nonmelanoma skin cancer) or any
             history of breast or endometrial cancer

          -  Has a known history or current episode of:

               1. New York Heart Association Stage ≥ 2 hypertension (systolic blood pressure > 160
                  mmHg or diastolic blood pressure > 100 mmHg) at screening and/or baseline.
                  Subjects with hypertension that has been treated and controlled with medication
                  for ≥ 2 weeks prior to screening are eligible for participation

               2. Recent myocardial infarction or arterial or venous thromboembolic event (within 1
                  year) or a history of more than 1 myocardial infarction or arterial or venous
                  thromboembolic event

               3. Cardiac-related syncopal event within the past year

               4. Cardio or cerebral vascular disease requiring surgical intervention (e.g., bypass
                  surgery, angioplasty). For subjects with previous stent placement, please contact
                  the medical monitor

               5. Congestive heart failure of Stage > 2 according to New York Heart Association
                  criteria

               6. Angina pectoris

          -  Has a current or past history of any physical condition that, in the investigator's
             opinion, might put the subject at risk, impact the absorption of the study drug, or
             interfere with interpretation of study