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New treatment option for Arginine Vasopressin Deficiency
Official title Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
ClinicalTrials.gov ID: NCT07568509
What this study is testing
What is Norethindrone Acetate-Ethinyl Estradiol?
Norethindrone Acetate-Ethinyl Estradiol is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for arginine vasopressin deficiency.
Also referred to as Estrogen-progestin.
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
- An open-labeled, interventional pilot trial, 10 youth with AVP-D and 10 PD matched for age, sex, and BMI will be recruited from Pediatric Endocrinology and Neuroendocrinology at Massachusetts General Hospital and in the community. This study tests the hypothesis that oral estrogen/progestin will stimulate endogenous oxytocin release in control subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 21
You may be able to join if
- (participants with AVP-D):
- AVP-D diagnosed in clinic using standard of care diagnostic tools;
- Stable pituitary hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline);
- If on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits;
- English language proficiency. (participants with hypopituitary disease):
You likely can't join if
- (all participants):
- History of pulmonary embolism or unprovoked deep venous thrombosis;
- History of breast/endometrial cancer as well as current therapies on estrogen modulators/blockers (i.e., tamoxifen, raloxifene, aromatase inhibitors);
- History of stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease;
- Pregnancy or breastfeeding within the last 8 weeks;
- Medication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication;
See the full eligibility criteria
- (participants with AVP-D):
- AVP-D diagnosed in clinic using standard of care diagnostic tools;
- Stable pituitary hormone replacement (no change in dose of hormone replacement in six weeks prior to baseline);
- If on estrogen/progestin, female participants agree to stop for at least 6 weeks prior to Main study visits;
- English language proficiency. (participants with hypopituitary disease):
- Hypopituitary disease diagnosis;
- If receiving pituitary hormone replacement, no change in dose in six weeks prior to baseline);
- If on estrogen/progestin, participants agree to stop for at least 6 weeks prior to Main study visits;
- English language proficiency.
- (all participants):
- History of pulmonary embolism or unprovoked deep venous thrombosis;
- History of breast/endometrial cancer as well as current therapies on estrogen modulators/blockers (i.e., tamoxifen, raloxifene, aromatase inhibitors);
- History of stroke, transient ischemic attack, myocardial infarction, angina pectoris, or peripheral arterial disease;
- Pregnancy or breastfeeding within the last 8 weeks;
- Medication changes within 2 weeks of enrollment or within 5 half-lives of the respective medication;
- History of stage 3 chronic kidney disease or cirrhosis;
- Any significant illness or condition that the investigator determines could interfere with study participation, data collection or safety;
- Active tobacco smoking or nicotine patch use;
- Psychosis or active suicidality.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
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 all sexes, 7 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.