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New treatment option for Menstrual Cycle
Official title Oxytocin and Reward Processing in Women
ClinicalTrials.gov ID: NCT06222749
What this study is testing
What is Intranasal oxytocin administration?
Intranasal oxytocin administration is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for menstrual cycle.
Also referred to as Syntocinon.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Oxytocin is a hypothalamic neuropeptide that is best known for its peripheral physiological effects in the female organism i.e., uterine contractions during birth. The neuropeptide furthermore affects reward processing and metabolic functions such as eating behavior and body weight.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40, women only. Healthy volunteers may be eligible.
You may be able to join if
- Body-mass index (BMI): 18-28 kg/m2
- Sex: female (since birth)
- Normal or corrected vision
- Natural menstrual cycle (NC) or intake of hormonal oral contraceptives (OC)
- NC: No hormonal contraception for at least 6 months; regular menstrual cycle (between 25 and 31 days) prior to participation
You likely can't join if
- No German language fluency (due to German language test content)
- Smoking
- Medication taken within the last 6 weeks (except for OCs in the respective group)
- Current neurological or psychiatric disease (anamnestic survey)
- Current medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or...
- Pregnancy, delivery and lactation (current and within the last year; anamnestic survey, current pregnancy test)
See the full eligibility criteria
- Body-mass index (BMI): 18-28 kg/m2
- Sex: female (since birth)
- Normal or corrected vision
- Natural menstrual cycle (NC) or intake of hormonal oral contraceptives (OC)
- NC: No hormonal contraception for at least 6 months; regular menstrual cycle (between 25 and 31 days) prior to participation
- OC: No hormonal contraception for at least 4 months, regular intake of OC pill
- No German language fluency (due to German language test content)
- Smoking
- Medication taken within the last 6 weeks (except for OCs in the respective group)
- Current neurological or psychiatric disease (anamnestic survey)
- Current medical problems such as hormonal, metabolic, or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure)
- Pregnancy, delivery and lactation (current and within the last year; anamnestic survey, current pregnancy test)
- Premenstrual dysphoric disorder (PMDD), endometriosis or polycystic ovary syndrome (PCOS)
- Shift work
- NC: Any kind of hormonal treatment or contraception
- OC: Any kind of hormonal treatment or contraception (except OCs)
- Contraindication for MRI:
- Non-removable metal objects on or in the body
- Tattoos (if MRI-incompatible according to expert guidelines)
- Pathological hearing or increased sensitivity to loud noise
- Claustrophobia
- Operation less than three months ago
- Neurological disease or injury
- Moderate or severe head injury
- Intake of antidepressants or neuroleptics
- Restricted vision
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.