TerminatedPhase 2

Safety and Efficacy Study of AR08 for the Treatment of Vasomotor Symptoms (VMS)

Stopped: Study stopping criteria met with regards to vital sign measurements post dose.

United States32 participantsStarted 2014-01

Plain-language summary

The purpose of this study is to determine the effective dose or dose range of AR08 in the treatment of VMS in menopausal females.

Age range41 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Generally healthy female \> 40 years of age with a body mass index (BMI) ≤ 40;
✓. Has undergone menopause defined as any of the following:
✓. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week

✕. Resting systolic blood pressure (SBP) \<110 mmHg, resting diastolic blood pressure (DBP) \<50 mm Hg, or a resting heart rate (HR) \<60 beats per minute while awake;
✕. Subjects with pre-existing orthostatic hypotension at Screening;
✕. Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
✕. History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications

Mean change from Baseline in the frequency and severity of moderate to severe hot flashes

Timeframe: Weeks 4 and 12

NCT IDNCT02049164

SponsorArbor Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05

Who can participate

Age range41 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Generally healthy female \> 40 years of age with a body mass index (BMI) ≤ 40;
✓. Has undergone menopause defined as any of the following:
✓. Experience a minimum of 7 moderate to severe hot flushes per day or 50 moderate to severe hot flushes per week

✕. Resting systolic blood pressure (SBP) \<110 mmHg, resting diastolic blood pressure (DBP) \<50 mm Hg, or a resting heart rate (HR) \<60 beats per minute while awake;
✕. Subjects with pre-existing orthostatic hypotension at Screening;
✕. Use of oral estrogen-, progestin-, androgen-, or selective estrogen receptor modifier (SERM) -containing drug products within 8 weeks prior to Screening; use of transdermal hormone products within 8 weeks prior to Screening; use of vaginal hormone products (rings, creams, gels) within 4 weeks prior to Screening; use of intrauterine progestins within 8 weeks prior to Screening; use of progestin implants or estrogen injectables within 3 months prior to Screening; use of estrogen pellet or progestin injectables within 6 months prior to Screening;
✕. History of daily usage (at least 28 days/month) of either of the following during the month prior to initiation of Screening: Antihypertensives or Prophylactic antimigraine medications