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NCT06357442
Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.
trial in Primary Ovarian Insufficiency in 34 participants. Currently enrolling.
1 July 2026
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 34 |
| Start date | 1 July 2024 |
| Primary completion | 1 July 2026 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across United States |
Conditions studied
- Primary Ovarian Insufficiency — all drugs for Primary Ovarian Insufficiency →
- Hypogonadotropic Hypogonadism — all drugs for Hypogonadotropic Hypogonadism →
- Hormone Replacement Therapy — all drugs for Hormone Replacement Therapy →
Sponsor
University of Colorado, Denver
Who can join
Adults 12 to 25, female only, with Primary Ovarian Insufficiency or Hypogonadotropic Hypogonadism. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this observational study is to compare endometrial stripe thickness in adolescent and young adult (AYA) patients with a uterus on estrogen replacement therapy using oral progesterone versus the etonogstrel implant for endometrial protection. The main questions it aims to answer are: Aim 1: Characterize the mean endometrial thickness in AYA on estrogen hormone replacement therapy before initiation of progesterone therapy Aim 2: Characterize the mean changes and variability in endometrial thickness in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone Aim 3: Assess satisfaction, side effects, bleeding patterns, any progesterone modifications, and adherence in AYA treated for 6 months with either etonogestrel implant or continuous progesterone Participants will be asked to: * Get two pelvic ultrasounds * Fill out two surveys * Continue their current hormone replacement therapy * Initiate one of two progesterone therapies (prometrium 100mg daily or Nexplanon) Researchers will compare the change in endometrial thickness after 6 months of progesterone use to see if there is a significant difference in the mean change between the prometrium and Nexplanon groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06357442
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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 NCT06357442 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 6 December 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/NCT06357442.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing