Recruitment

Recruitment Status
Completed

Inclusion Criterias

On the Screening Hot Flush Diary, demonstrate compliance (by indicating they filled out the diary "all of the time" or "most of the time") on at least 4 out of 7 days.
6 weeks of surgical amenorrhea following bilateral oophorectomy with or without hysterectomy; or
hysterectomy alone with serum FSH >30 mIU/ml.
...
On the Screening Hot Flush Diary, demonstrate compliance (by indicating they filled out the diary "all of the time" or "most of the time") on at least 4 out of 7 days.
6 weeks of surgical amenorrhea following bilateral oophorectomy with or without hysterectomy; or
hysterectomy alone with serum FSH >30 mIU/ml.
Provide written informed consent.
6 months of spontaneous amenorrhea with serum FSH >30 mIU/ml;
Currently receive medical care from a health care provider.
12 months of spontaneous amenorrhea;
During Screening, the patient must report they are having at least 5 moderate to severe hot flashes per day or 35 moderate to severe hot flashes per week.
Postmenopausal women aged 40-65 years.

Exclusion Criterias

Currently taking morphine or other opiates on a chronic basis.
Participants with polyps or other abnormal uterine masses (with the exception of fibroids) on TVUS.
History of deep vein thrombosis or pulmonary embolism.
...
Currently taking morphine or other opiates on a chronic basis.
Participants with polyps or other abnormal uterine masses (with the exception of fibroids) on TVUS.
History of deep vein thrombosis or pulmonary embolism.
Any concern or medical, emotional or psychiatric condition that, in the investigator's opinion, would preclude the participant from providing informed consent, completing questionnaires, adhering to the protocol or completing the trial (e.g., severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia).
Active liver disease or a history of impaired hepatic function.
Use of herbal or dietary supplements purported to treat hot flushes or herbal/dietary supplements with known estrogenic or progestogenic activity within 2 weeks of screening.
Within 12 months of screening, abnormal Pap smear or pelvic examination that is suggestive of cancer, or refused Pap smear or pelvic exam.
History of malignancy, with the exception of non-melanoma skin cancer or cervical cancer that was diagnosed with treatment completion more than 1 year prior to screening (i.e., if a participant had cervical cancer or basal cell carcinoma that was diagnosed and fully treated 2 years prior to screening, the participant would be eligible for the study).
History of severe food or medicine allergies resulting in anaphylactic shock, requiring hospitalization, or requiring use of epinephrine.
Unexplained uterine bleeding within six months prior to screening.
Uncontrolled hypertension (≥160/100 at baseline or within 4 weeks prior to screening) or a history of transient ischemic attack or cerebrovascular accidents.
Within 12 months of screening, abnormal mammogram or breast examination that is suggestive of cancer, or refused mammogram or breast exam.
Clinical evidence of active ischemic cardiovascular disease or history of cardiovascular disease.
History of severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS), uncontrolled inflammatory bowel disease (IBD), or unexplained weight loss.
BMI >35 kg/m2
Use of prescription medications known to be possibly effective for the treatment of hot flushes within: 1 week prior to screening for vaginal hormonal products (rings, creams, gels), 4 weeks prior to screening for transdermal estrogen alone or estrogen/progestin products, 4 weeks prior to screening for testosterone products (oral, patch, gel or cream), 8 weeks prior to screening for oral estrogen and/or progestin therapy and intrauterine progestin therapy, 3 months prior to screening for progestin implants and estrogen alone injectable drug therapy and 6 months prior to screening for estrogen pellet therapy or progestin injectable drug therapy.
Any laboratory findings out of normal range deemed clinically significant.
Use of herbal or dietary supplements within 2 weeks prior to screening, unless the participant agrees not to change the frequency or dose of the herbal supplement for the entire duration of study treatment.
Active gallbladder disease.
Use of another investigational agent within 1 month prior to screening.
Known carrier of BRCA1 or BRCA2.
History of substance abuse within the past year.
Transvaginal Ultrasound (TVUS) double-wall endometrium of >8mm on TVUS.
History of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.

Summary

Conditions
Hot Flashes
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 40 years and 65 years
Gender
Only females

Inclusion Criterias

On the Screening Hot Flush Diary, demonstrate compliance (by indicating they filled out the diary "all of the time" or "most of the time") on at least 4 out of 7 days.
6 weeks of surgical amenorrhea following bilateral oophorectomy with or without hysterectomy; or
hysterectomy alone with serum FSH >30 mIU/ml.
...
On the Screening Hot Flush Diary, demonstrate compliance (by indicating they filled out the diary "all of the time" or "most of the time") on at least 4 out of 7 days.
6 weeks of surgical amenorrhea following bilateral oophorectomy with or without hysterectomy; or
hysterectomy alone with serum FSH >30 mIU/ml.
Provide written informed consent.
6 months of spontaneous amenorrhea with serum FSH >30 mIU/ml;
Currently receive medical care from a health care provider.
12 months of spontaneous amenorrhea;
During Screening, the patient must report they are having at least 5 moderate to severe hot flashes per day or 35 moderate to severe hot flashes per week.
Postmenopausal women aged 40-65 years.

Exclusion Criterias

Currently taking morphine or other opiates on a chronic basis.
Participants with polyps or other abnormal uterine masses (with the exception of fibroids) on TVUS.
History of deep vein thrombosis or pulmonary embolism.
...
Currently taking morphine or other opiates on a chronic basis.
Participants with polyps or other abnormal uterine masses (with the exception of fibroids) on TVUS.
History of deep vein thrombosis or pulmonary embolism.
Any concern or medical, emotional or psychiatric condition that, in the investigator's opinion, would preclude the participant from providing informed consent, completing questionnaires, adhering to the protocol or completing the trial (e.g., severe illness, plans to move, substance abuse, significant psychiatric problems, or dementia).
Active liver disease or a history of impaired hepatic function.
Use of herbal or dietary supplements purported to treat hot flushes or herbal/dietary supplements with known estrogenic or progestogenic activity within 2 weeks of screening.
Within 12 months of screening, abnormal Pap smear or pelvic examination that is suggestive of cancer, or refused Pap smear or pelvic exam.
History of malignancy, with the exception of non-melanoma skin cancer or cervical cancer that was diagnosed with treatment completion more than 1 year prior to screening (i.e., if a participant had cervical cancer or basal cell carcinoma that was diagnosed and fully treated 2 years prior to screening, the participant would be eligible for the study).
History of severe food or medicine allergies resulting in anaphylactic shock, requiring hospitalization, or requiring use of epinephrine.
Unexplained uterine bleeding within six months prior to screening.
Uncontrolled hypertension (≥160/100 at baseline or within 4 weeks prior to screening) or a history of transient ischemic attack or cerebrovascular accidents.
Within 12 months of screening, abnormal mammogram or breast examination that is suggestive of cancer, or refused mammogram or breast exam.
Clinical evidence of active ischemic cardiovascular disease or history of cardiovascular disease.
History of severe chronic diarrhea, chronic constipation, uncontrolled irritable bowel syndrome (IBS), uncontrolled inflammatory bowel disease (IBD), or unexplained weight loss.
BMI >35 kg/m2
Use of prescription medications known to be possibly effective for the treatment of hot flushes within: 1 week prior to screening for vaginal hormonal products (rings, creams, gels), 4 weeks prior to screening for transdermal estrogen alone or estrogen/progestin products, 4 weeks prior to screening for testosterone products (oral, patch, gel or cream), 8 weeks prior to screening for oral estrogen and/or progestin therapy and intrauterine progestin therapy, 3 months prior to screening for progestin implants and estrogen alone injectable drug therapy and 6 months prior to screening for estrogen pellet therapy or progestin injectable drug therapy.
Any laboratory findings out of normal range deemed clinically significant.
Use of herbal or dietary supplements within 2 weeks prior to screening, unless the participant agrees not to change the frequency or dose of the herbal supplement for the entire duration of study treatment.
Active gallbladder disease.
Use of another investigational agent within 1 month prior to screening.
Known carrier of BRCA1 or BRCA2.
History of substance abuse within the past year.
Transvaginal Ultrasound (TVUS) double-wall endometrium of >8mm on TVUS.
History of chronic hepatitis B or C, hepatitis within the past 3 months, or HIV infection.

Locations

San Diego, California, 92108
San Diego, California, 92108

Tracking Information

NCT #
NCT01957306
Collaborators
Not Provided
Investigators
  • Principal Investigator: William Koltun, MD Medical Center for Clinical Research
  • William Koltun, MD Medical Center for Clinical Research