A two part study to a) investigate the reproducibility of the vaginal photoplethysmography (VPP) technique in healthy post-menopausal volunteers and subjects suffering from Female Sexual Arousal Disorder (FSAD) and b) a randomised double blind, placebo controlled 4-way crossover study to investigate the effect of single oral doses (10, 50 and 400mg) of UK-447,841 on vaginal blood flow in post-menopausal subjects suffering from FSAD. - N/A

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001379-20-SE

Enrollment

Registered

2004-08-02

Start date

2004-09-28

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Sexual Arousal Disorder (FSAD) Classification code 10062641

Interventions

Product Name: N/A Product Code: UK-447,841 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: UK-447.841 Other descriptive name: N/A Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All subjects 1. Post-menopausal female subjects aged 45-65 2. Post-menopausal status is defined by a documented history of: a) Naturally amenorrhoeic for > 1 year or b) A six month history of amenorrhoeic and an FSH level of > 50IU/L and serum estradiol =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: All subjects 1. Subjects who have an estradiol plasma concentration of less than 40pg/mL. (N.B. those subjects taking HRT in the form of conjugated estrogens are not required to have a minimum estradiol concentration of 40 pg/mL, provided that in the opinion of the investigator they are clinically estradiol replete, e.g. vasomotor symptoms controlled and reversal or absence of vulval / vaginal atrophy). 2. Subjects who have a free plasma testosterone concentration 20mmHg and diastolic blood pressure of >10mmHg at screening. (This criterion will only apply to subjects recruited for Part B of the study.) 19. Subjects with any other major psychological or sexual disorder, not otherwise listed in the inclusion criteria, which is considered to be the primary diagnosis explaining the sexual dysfunction. 20. Subjects with otherwise treatable causes of FSAD including inadequately controlled diabetes, t

Design outcomes

Primary

Measure	Time frame
Main Objective: Part A: Primary: To investigate the reproducibility of the vaginal photoplethysmography (VPP) technique in healthy post-menopausal female volunteers and post-menopausal subjects suffering from FSAD. Part B: Primary: To investigate the effect of single doses of UK-447,841 on vaginal blood flow (VBF) as measured by VPP in post-menopausal subjects suffering from FSAD.;Secondary Objective: Part A: To assess the degree of undesirable artefacts and fluctuations in the vaginal pulse amplitude (VPA) traces. To assess the variability of subjective feeling of arousal at baseline and during visual sexual stimulation (VSS). To investigate differences in VPA between healthy volunteers and subjects suffering from FSAD. Part B: To investigate the suitability of this technique in determining sensitivity to change on VBF following dosing with UK-447,841.To assess the correlation between changes in VPA and subjective feeling of arousal during sexual arousal.To investigate the safety and toleration of single oral doses of UK-447,841 in FSAD subjects.To determine plasma concentrations of UK-447,841 in FSAD subjects. To determine the effect of UK-447,841 on levels of plasma biomarkers such as VIP, ANP, big endothelin and cGMP.;Primary end point(s): Part A: VPA mean change from baseline to mean VSS as measured by VPP. VPA mean change from baseline to maximum level during VSS as measured by VPP. Part B: VPA mean change from pre-dose baseline to mean VSS as measured by VPP. VPA mean change from pre-dose baseline to maximum level during VSS as measured by VPP.	—

Measure

Time frame

Main Objective: Part A: Primary: To investigate the reproducibility of the vaginal photoplethysmography (VPP) technique in healthy post-menopausal female volunteers and post-menopausal subjects suffering from FSAD. Part B: Primary: To investigate the effect of single doses of UK-447,841 on vaginal blood flow (VBF) as measured by VPP in post-menopausal subjects suffering from FSAD.;Secondary Objective: Part A: To assess the degree of undesirable artefacts and fluctuations in the vaginal pulse amplitude (VPA) traces. To assess the variability of subjective feeling of arousal at baseline and during visual sexual stimulation (VSS). To investigate differences in VPA between healthy volunteers and subjects suffering from FSAD. Part B: To investigate the suitability of this technique in determining sensitivity to change on VBF following dosing with UK-447,841.To assess the correlation between changes in VPA and subjective feeling of arousal during sexual arousal.To investigate the safety and toleration of single oral doses of UK-447,841 in FSAD subjects.To determine plasma concentrations of UK-447,841 in FSAD subjects. To determine the effect of UK-447,841 on levels of plasma biomarkers such as VIP, ANP, big endothelin and cGMP.;Primary end point(s): Part A: VPA mean change from baseline to mean VSS as measured by VPP. VPA mean change from baseline to maximum level during VSS as measured by VPP. Part B: VPA mean change from pre-dose baseline to mean VSS as measured by VPP. VPA mean change from pre-dose baseline to maximum level during VSS as measured by VPP.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026