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A total of 403 subjects were screened at 8 medical/research sites located in the US (2 centers) and Canada (6 centers) and 218 subjects were randomized. The first subject first visit was on 28-JUN-2007 and the last subject last visit was on 23-MAY-2008.
Placebo: Placebo vaginal suppositor...
DHEA (0.25%): Vaginal suppository c...
DHEA (0.50%): Vaginal suppository c...
DHEA (1.00%): Vaginal suppository c...
Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Investigators shall provide to the SPONSOR 30 days prior to submission all documents for publication, presentation, etc that report any trial results. The SPONSOR shall have editorial rights on documents and the right to review/comment with regard to (1) proprietary information, (2) accuracy of the information, (3) correctness of the scientific evaluation/conclusions and (4) to ensure that the information is fairly balanced and in compliance with regulations.
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