Oxtocin administration experiment(Menstrual cycle analysis)

JRCT ID: jRCTs051210118

Registered date:09/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy Females
• Date of first enrollment: 01/12/2021
• Target sample size: 250
• Study type: Interventional
• Intervention(s): A double-blind, placebo-controlled test of nasal oxytocin spray

Outcome(s)

• Primary Outcome: Selection rate of "Personal Performance" or "Tournament Reward" in the economic experiment to measure the competitive preferences after administration of the drug (Oxytocin or Placebo).

Secondary Outcome

1.The degree of trusting others calculated based on the "investment " and "return " in the "economic experiment to measure social preference " conducted after administration of the test drug (oxytocin nasal spray or placebo)
2. Oxytocin concentration in saliva
3. Evaluation of the relationship between the primary endpoints and the above secondary endpoints in the follicular phase and luteal phase
4. Adverse events
5. Demographic survey by questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

For those who meet all of the following criteria.
(1) Premenopausal healthy women
(2) Age: 18<= and <45 at the point of informed consent
(3) No serious disease under medical treatment
A healthy woman is defined as a woman who does not have any abnormality that meets the exclusi on criteria and who has not been found to have any abnormality that requires treatment in a school or workplace examination conducteds after fiscal 2021.To determine the eligibility criteria,it is necessary to submit the results of a school or workplace medical checkup, and following items are confirmed by the
docors.
Check items:
(1) The absence of significant edema
(2) Systolic blood pressure < 140 mgHg and diastolic blood pressure < 90 mmHg
(3) No possibility of pregnant
(4) No ECG abnormalities that require awareness or treatment of arrhythmia

Exclude criteria

Those who fall under any of the following criteria will be excluded from the research subjects of this clinical research.
(1) Pregnant and breastfeeding women(Including within 1 year after delivery)
(2) History of tretment with oxytocin
(3) History of head injury with impaired consciousness for more than 5 minutes
(4) Drug dependence or alcohol dependence or their previous history
(5) History of water intoxication with consciousness or seizures
(6) Polydipsia (remarkably daily heavy drinking more than 2.5L per day)
(7) Those who are aware of arrhythmia or have abnormal ECG
(8) Those who taking pill
(9) Any other interested person
(10)When the research investigator determines inappropriate case for the other reasons.
(e.g., when drug absorption through the nasal mucosa is considered to be difficult due to previous nasal surgery)

Related Information

• Primary Sponsor: Satoshi Nakagawa
• Secondary Sponsor: Otake Fumio,Ministry of Education, Culture, Sports, Science and Technology