The role of nitric oxide on reproductive hormone responses in healthy individuals and individuals with reproductive disorders. Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will attend six study visits in a balanced random order, each involving administration of one of the following intervention combinations:
A nitric oxide (NO) enhancer/donor (administered
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: GROUP A: PEOPLE WITH NORMAL REPRODUCTIVE FUNCTION: 1. Aged 18 years to 35 years 2. Ability to give informed consent GROUP B: PEOPLE WITH REDUCED REPRODUCTIVE FUNCTION: 1. Aged 18 years or older 2. Ability to give informed consent
Exclusion criteria
Exclusion criteria: GROUP A: PEOPLE WITH NORMAL REPRODUCTIVE FUNCTION: 1. Medical or psychological conditions that would impair their ability to participate reliably in the study or give informed consent. 2. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer. 3. Severe allergies, or allergy specific to Sildenafil, Nitroglycerine or other ingredients of the patch/medication 4. Significant anaemia (Hb<11 g/dl) 5. Pregnancy 6. Participation in any research study within the preceding 2 weeks GROUP B: PEOPLE WITH REDUCED REPRODUCTIVE FUNCTION: 1. Medical or psychological conditions that would impair their ability to participate reliably in the study or give informed consent. 2. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer. 3. Severe allergies, or allergy specific to Sildenafil, Nitroglycerine or other ingredients of the patch/medication 4. Significant anaemia (Hb<11 g/dl) 5. Pregnancy 6. Participation in any research study within the preceding 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in kisspeptin-stimulated luteinising hormone (LH) levels in the presence of a nitric oxide donor/enhancer, measured using blood samples collected at baseline and every 10 minutes for up to 480 minutes during each of six study visits, and analysed using established laboratory techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in kisspeptin-stimulated blood parameters, including follicle-stimulating hormone (FSH), oestradiol, progesterone, and testosterone, in the presence of a nitric oxide donor/enhancer, measured using blood samples collected at baseline and at regular intervals (at a minimum every 10 minutes) for up to 480 minutes during each of six study visits, and analysed using established laboratory techniques 2. Change in Gonadotrophin Releasing Hormone (GnRH)-stimulated blood parameters, including LH, FSH, oestradiol, progesterone, and testosterone, in the presence of a nitric oxide donor/enhancer, measured using blood samples collected at baseline and at regular intervals (at a minimum every 10 minutes) for up to 480 minutes during each of six study visits, and analysed using established laboratory techniques 3. Safety assessments, including a) Adverse events, monitored continuously throughout each of the six study visits; b) Blood pressure and heart rate, measured using standard clinical methods at the beginning of each study visit, at regular intervals during the visit, and at the end of the visit | — |
Countries
England, United Kingdom
Contacts
Public ContactJovanna Tsoutsouki
Outcome results
None listed