Ignite Creation Date:
2024-05-06 @ 1:36 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857596
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2013-05-10
Brief Title:
Phase 1b2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety
Sponsor:
S1 Biopharma Inc
Organization:
S1 Biopharma Inc
Study Overview
Official Title:
A Phase 1-b Non-blinded Study of Safety Tolerability and Efficacy of Lorexys in Premenopausal Women With Hypoactive Sexual Desire Disorder
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PURPLE
Brief Summary:
The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree
Detailed Description:
Women are diagnosed with Hypoactive sexual desire disorder HSDD if they experience chronic loss of desire for sex together with significant distress or interpersonal difficulties due to this lack of desire HSDD can have a serious effect on emotional well-being and interpersonal relationships
There are no US Food and Drug Administration-approved treatments for HSDD Off-label treatments include testosterone which is not always effective and can be accompanied by side effects such as excess hair growth acne and decreases in high-density lipoprotein HDL cholesterol levels
Research in laboratory animals and clinical observations in humans suggest that re-balancing chemical messengers in the brain may stimulate sexual desire S1 Biopharmas Lorexys is a novel use fixed-dose combination FDC in an oral pill Lorexys combines two agents intended to restore balance to the brains centers that control sexual function Such effects are hoped to help women with HSDD
The compound is Phase 2-ready without prior trials Phase I safety studies because the two agents have often been used together individually they are FDA-approved for treating other disorders depression for example and in a large US survey the two were taken together in about 23 of patients who were prescribed one of the two agents
This research study requires subjects to take three different study medications for four weeks each with at least a one-week wash-out period after each and to report on rating scales how they feel The medication is open-label the subjects can see which medication they are receiving That should not interfere with the evaluations or cause a big placebo effect because only a low proportion of women with HSDD have responded to a placebo in prior research studies of other compounds when using the same measures of efficacy
Participation lasts 16 weeks with 8 clinic visits A weekly but no daily self-rating is required between visits
There are no US Food and Drug Administration-approved treatments for HSDD Off-label treatments include testosterone which is not always effective and can be accompanied by side effects such as excess hair growth acne and decreases in high-density lipoprotein HDL cholesterol levels
Research in laboratory animals and clinical observations in humans suggest that re-balancing chemical messengers in the brain may stimulate sexual desire S1 Biopharmas Lorexys is a novel use fixed-dose combination FDC in an oral pill Lorexys combines two agents intended to restore balance to the brains centers that control sexual function Such effects are hoped to help women with HSDD
The compound is Phase 2-ready without prior trials Phase I safety studies because the two agents have often been used together individually they are FDA-approved for treating other disorders depression for example and in a large US survey the two were taken together in about 23 of patients who were prescribed one of the two agents
This research study requires subjects to take three different study medications for four weeks each with at least a one-week wash-out period after each and to report on rating scales how they feel The medication is open-label the subjects can see which medication they are receiving That should not interfere with the evaluations or cause a big placebo effect because only a low proportion of women with HSDD have responded to a placebo in prior research studies of other compounds when using the same measures of efficacy
Participation lasts 16 weeks with 8 clinic visits A weekly but no daily self-rating is required between visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None