HealthyEarly Phase 1NCT03144115
Does Oxytocin Modulate Rewarding Effects in Women and Fluctuating Across the Menstrual Cycle
A Early Phase 1 study testing Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The aim of the study is to explore how the rewarding effect of men's verbal compliment is modulated by oxytocin and gonadal hormone in a romantic context. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jul 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single in the past 3 months
- Healthy subjects with regular menstrual cycle
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
University of Electronic Science and Technology of Chia
Chengdu, Sichuan, 611731
About this study
Official title: Does Oxytocin Modulate Rewarding Effect of Metaphorical Compliments Fluctuating With Women's Fertility and Luteal Phase in a Romantic Context
The aim of the study is to explore how the rewarding effect of men's verbal compliment is modulated by oxytocin and gonadal hormone in a romantic context.
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called oxytocin treatment
PlacebosDrug
Also called placebo control
| Study group | Role | What they receive |
|---|---|---|
| oxytocin fertility | Experimental | intranasal oxytocin administration (24IU) in women's fertility phase (LH>40 mIU/ml) Receives: Drug: Oxytocin |
| placebos fertility | Placebo comparator | intranasal placebo administration (24IU) in women's fertility phase (LH>40 mIU/ml) Receives: Drug: Placebos |
| oxytocin luteal | Experimental | intranasal oxytocin administration (24IU) in women's luteal phase (LH<30 mIU/ml) Receives: Drug: Oxytocin |
| placebos luteal | Placebo comparator | intranasal placebos administration (24IU) in women's luteal phase (LH<30 mIU/ml) Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin effect on neural activity as assessed via fMRI towards reward between fertility and luteal phases
Effects of oxytocin versus placebo nasal spray on neural processing of reward will be compared between different cycle phases
Measured: 45min-120min after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startOct 2016
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
- Investigators
- Keith M Kendrick, Dr., Principal investigator, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144115
- Sponsor's protocol ID
- UESTC-neuSCAN-22
- Status last verified
- Oct 2018
- First submitted
- 4 May 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao Z, Ma X, Zhou X, Xin F, Gao S, Kou J, Becker B, Kendrick KM. Oxytocin Reduces the Attractiveness of Silver-Tongued Men for Women During Mid-Cycle. Front Neurosci. 2022 Apr 28;16:760695. doi: 10.3389/fnins.2022.760695. eCollection 2022.
PubMed 35573309
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oxytocin Modulate Rewarding Effect of Metaphorical Compliments Fluctuating With Women's Fertility and Luteal Phase in a Romantic Context
- ClinicalTrials.gov ID
- NCT03144115
- Acronym / sponsor ID
- UESTC-neuSCAN-22
- Conditions
- Healthy
- Keywords
- oxytocin, sex hormone, verbal reward, mate selection, metaphorical language
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to explore how the rewarding effect of men's verbal compliment is modulated by oxytocin and gonadal hormone in a romantic context.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| oxytocin fertility | Experimental | Drug: Oxytocinintranasal oxytocin administration (24IU) in women's fertility phase (LH>40 mIU/ml) |
| placebos fertility | Placebo comparator | Drug: Placebosintranasal placebo administration (24IU) in women's fertility phase (LH>40 mIU/ml) |
| oxytocin luteal | Experimental | Drug: Oxytocinintranasal oxytocin administration (24IU) in women's luteal phase (LH<30 mIU/ml) |
| placebos luteal | Placebo comparator | Drug: Placebosintranasal placebos administration (24IU) in women's luteal phase (LH<30 mIU/ml) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single in the past 3 months
- Healthy subjects with regular menstrual cycle
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: oxytocin treatment | Drug | oxytocin fertility, oxytocin luteal |
| PlacebosAlso: placebo control | Drug | placebos fertility, placebos luteal |
Primary outcome
Oxytocin effect on neural activity as assessed via fMRI towards reward between fertility and luteal phases
Time frame: 45min-120min after treatment
Effects of oxytocin versus placebo nasal spray on neural processing of reward will be compared between different cycle phases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 35573309Gao Z, Ma X, Zhou X, Xin F, Gao S, Kou J, Becker B, Kendrick KM. Oxytocin Reduces the Attractiveness of Silver-Tongued Men for Women During Mid-Cycle. Front Neurosci. 2022 Apr 28;16:760695. doi: 10.3389/fnins.2022.760695. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith M Kendrick, Dr. principal investigator
University of Electronic Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin effect on neural activity as assessed via fMRI towards reward between fertility and luteal phases (time frame: 45min-120min after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.