PK Study of Testosterone Nasal Gel (TBS-2) in Healthy Premenopausal Women
An Open-label, Single and Multiple Application of Intranasal Testosterone Gel (TBS-2) in Healthy Premenopausal Female Subjects at Three Dose Levels
Sponsor: Acerus Pharmaceuticals Corporation
A PHASE1 clinical study on Female Sexual Dysfunction, this trial is completed. The trial is conducted by Acerus Pharmaceuticals Corporation and has accumulated 12 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)This is a 2 Period study that requires overnight stays in clinic. Blood samples are required at all visits including sampling at predefined time periods during the overnight stays.
Period I
Subjects were checked-in on Day 1 Period I to start their baseline testosterone measurement (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They remained institutionalized until Day 4 morning, and were checked out after the 48 hour blood draw and study close-out for those that did not continue with Period II.
Period II (Multi-Dose)
At the end of Period 1, a total of 8 subjects sampled from these 3 cohorts, who were willing and able to continue with the multiple-dose portion of the study were selected to participate in Period 2. Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3, and were checked out after the 48 hour blood draw and study close-out.
This is a 2 Period study that requires overnight stays in clinic. Blood samples are required at all visits including sampling at predefined time periods during the overnight stays.
Period I
Subjects were checked-in on Day 1 Period I to start their baseline testosterone measurement (dependant on menstrual cycle, preferably within 48hr of start of the menstrual cycle). They remained institutionalized until Day 4 morning, and were checked out after the 48 hour blood draw and study close-out for those that did not continue with Period II.
Period II (Multi-Dose)
At the end of Period 1, a total of 8 subjects sampled from these 3 cohorts, who were willing and able to continue with the multiple-dose portion of the study were selected to participate in Period 2. Subjects were institutionalized starting on Day 1 of Visit 3 until Day 5 morning of Visit 3, and were checked out after the 48 hour blood draw and study close-out.
Status Flow
Change History
12 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE1
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE1
▶ Show 7 earlier versions
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Jan 2021 — Dec 2022 [monthly]
Completed PHASE1
-
Nov 2019 — Jan 2021 [monthly]
Completed PHASE1
-
Oct 2019 — Nov 2019 [monthly]
Completed PHASE1
-
Jun 2018 — Oct 2019 [monthly]
Completed PHASE1
-
Feb 2018 — Jun 2018 [monthly]
Completed PHASE1
-
Feb 2017 — Feb 2018 [monthly]
Completed PHASE1
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Sep 2011
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Acerus Pharmaceuticals Corporation
For direct contact, visit the study record on ClinicalTrials.gov .