- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03144115
Does Oxytocin Modulate Rewarding Effects in Women and Fluctuating Across the Menstrual Cycle
Does Oxytocin Modulate Rewarding Effect of Metaphorical Compliments Fluctuating With Women's Fertility and Luteal Phase in a Romantic Context
Study Overview
Detailed Description
To investigate whether oxytocin (24IU) might interact with female sex hormone in modulating the rewarding effect of compliment to women in a romantic context.
The study employs a double-blind, within-subject, placebo-control design. Women will be administered with the same drug twice (oxytocin or placebo) respectively the fertile and luteal phase followed by a MRI scanning. During fMRI participants will rate men's attraction based on their facial pictures of average attractiveness associated with compliments of different combination of form and topic. Each male face will be paired with two sentences of the same kind. After the fMRI participants will recall the judgment followed by a memory test during which they have to indicate whether the they have seen the face during scanning (old) or whether it is an unknown face (new).
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Sichuan
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Chengdu, Sichuan, China, 611731
- University of Electronic Science and Technology of Chia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Single in the past 3 months
- Healthy subjects with regular menstrual cycle
Exclusion Criteria:
- Pregnant, menstruating, taking oral contraceptives
- metal implanted, with tatoo, or hair dyed within 6 months
- participated in another intranasal experiment within 6 months
- with a history of past or current psychiatric or neurological disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oxytocin fertility
intranasal oxytocin administration (24IU) in women's fertility phase (LH>40 mIU/ml)
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Other Names:
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Placebo Comparator: placebos fertility
intranasal placebo administration (24IU) in women's fertility phase (LH>40 mIU/ml)
|
Other Names:
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Experimental: oxytocin luteal
intranasal oxytocin administration (24IU) in women's luteal phase (LH<30 mIU/ml)
|
Other Names:
|
Placebo Comparator: placebos luteal
intranasal placebos administration (24IU) in women's luteal phase (LH<30 mIU/ml)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxytocin effect on neural activity as assessed via fMRI towards reward between fertility and luteal phases
Time Frame: 45min-120min after treatment
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Effects of oxytocin versus placebo nasal spray on neural processing of reward will be compared between different cycle phases
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45min-120min after treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Keith M Kendrick, Dr., University of Electronic Science and Technology of China
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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