deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT01364623

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

Updated 12 times since 2017 Last updated: Oct 4, 2019 Started: Sep 30, 2011 Primary completion: Jan 31, 2012 Completion: Feb 29, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Feb 2018 · 12 months · monthly snapshotCompleted~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshotCompleted~Jun 2018 – ~Oct 2019 · 16 months · monthly snapshotCompleted~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshotCompleted~Nov 2019 – ~Jan 2021 · 14 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

12 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Present [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

Show 7 earlier versions
  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE1

  2. Nov 2019 — Jan 2021 [monthly]

    Completed PHASE1

  3. Oct 2019 — Nov 2019 [monthly]

    Completed PHASE1

  4. Jun 2018 — Oct 2019 [monthly]

    Completed PHASE1

  5. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE1

  6. Feb 2017 — Feb 2018 [monthly]

    Completed PHASE1

  7. 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

Sponsor contact:
  • Acerus Pharmaceuticals Corporation
Data source: Acerus Pharmaceuticals Corporation

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations