Does Size Matter: A Single Case Experimental Design of Limiting the Depth of Penetration During Intercourse
1 other identifier
interventional
12
1 country
1
Brief Summary
Our hypothesis is that reducing the length of the penis does not lead to loss of sexual satisfaction or emotional closeness in the female partner. This will be investigated by a single case experimental design in 12 couples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 7, 2019
CompletedFirst Posted
Study publicly available on registry
August 9, 2019
CompletedAugust 9, 2019
August 1, 2019
2.3 years
August 7, 2019
August 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Sexual Pleasure on a Visual Analogue Scale
Overall Sexual Pleasure on a Visual Analogue Scale between 0-100
Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Secondary Outcomes (2)
Sexual Pleasure from Intercourse on a Visual Analogue Scale
Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Emotional Connection on a Visual Analogue Scale
Change between Control phase (A) and phase B, C, or D through study completion, on average 8 weeks
Study Arms (4)
Control Ring
OTHER"Normal" intercourse with very thin (less than 0.5cm) ring randomised to either 3, 4 or 5 episodes of intercourse (Phase A)
1" RIng
EXPERIMENTALIntercourse wearing a 1" ring. Randomised to either 3, 4, or 5 episodes of intercourse (Phase B)
1.5" Ring
EXPERIMENTALIntercourse wearing a 1.5" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase C)
2" Ring
EXPERIMENTALIntercourse with a 2" ring randomised to either 3, 4, or 5 episodes of intercourse (Phase D)
Interventions
Eligibility Criteria
You may qualify if:
- Heterosexual couples in a stable relationship (defined as 6 months or more)
- Having regular intercourse (defined as on average twice a week).
You may not qualify if:
- Any current sexual dysfunction in either partner
- Any current emotional disorder in either partner
- Men with a micro-penis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Anxiety Disorders and Trauma
London, se5 8az, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Masking of female participant
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2019
First Posted
August 9, 2019
Study Start
March 1, 2017
Primary Completion
June 1, 2019
Study Completion
August 1, 2019
Last Updated
August 9, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 10 years
All original data