Last reviewed · How we verify
NCT04424576: OMG
Ovarian Morphology in Girls
trial in Amenorrhea in 60 participants. Currently enrolling.
31 March 2025
Quick facts
| Lead sponsor | Cornell University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 31 January 2020 |
| Primary completion | 31 March 2025 |
| Estimated completion | 31 March 2025 |
| Sites | 3 locations across United States |
Conditions studied
- Amenorrhea — all drugs for Amenorrhea →
- Oligomenorrhea — all drugs for Oligomenorrhea →
- Puberty — all drugs for Puberty →
Sponsor
Cornell University
Who can join
Adults 9 to 17, female only, with Amenorrhea or Oligomenorrhea. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Changes in the Bile Acid Pool and Timing of Female Puberty: Potential Novel Role of Hypothalamic TGR5.
Vanden Brink H, Vandeputte D, Brito IL, Ronnekleiv OK, et al · · 2024 · cited 11× · PMID 39082696 · DOI 10.1210/endocr/bqae098
Verify or expand the search:
- PubMed search for NCT04424576
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Amenorrhea
Currently open trials in the same condition.
- NCT06280807 — Observation of Environment and Reproductive-Endocrine Effects · recruiting
- NCT03916978 — Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women · Phase 2, PHASE3 · recruiting
- NCT01500447 — Inherited Reproductive Disorders · recruiting
Other Cornell University trials
Trials by the same sponsor.
- NCT07439198 — The Influence of Water Intake on Food Intake at Meals Varying in Moisture · NA · not yet recruiting
- NCT07224412 — A Digital Intervention to Promote Preschool Nutrition and Activity: The eHEROs Study · NA · recruiting
- NCT06880510 — The Locus Coeruleus, Norepinephrine and Cognitive Aging · NA · recruiting
- NCT06870526 — Feasibility of Online-supported Delivery Bringing Optimal Nutrition to Diverse Low-income Households With Children · NA · completed
- NCT06988410 — Income Volatility and Mental Health, Full Experiment · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04424576 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cornell University
- Last refreshed: 12 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04424576.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing