Recruiting

Micronized Progesterone vs. Etonogestrel

Sponsor:

University of Colorado, Denver

Code:

NCT06357442

Conditions

Primary Ovarian Insufficiency

Hypogonadotropic Hypogonadism

Hormone Replacement Therapy

Eligibility Criteria

Sex: Female

Age: 12 - 25

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Primary Ovarian Insufficiency

Hypogonadotropic Hypogonadism

Hormone Replacement Therapy

Study ID

NCT06357442

Start date

Jul 1, 2024

Status verified date

Dec, 2024

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 12-25 years at baseline
  • Female assigned at birth, with uterus
  • Diagnosis of primary ovarian insufficiency or hypogonadotropic hypogonadism, requiring estrogen replacement therapy
  • Receiving estradiol therapy-oral (1-2mg) or transdermal (0.05-0.1mg)-for at least 3 months
  • Never used progesterone therapy or discontinued progesterone therapy at least 90-days prior to enrollment
  • Consents to initiating progesterone therapy

Exclusion Criteria:

  • Uterine abnormality (e.g., Müllerian Anomaly, uterine fibroids)
  • Inability to characterize the endometrial lining on ultrasound
  • History of chemotherapy or radiation therapy
  • Inability to complete study questionnaire

Study Design

Enrollment

34 participants

Anticipated

Interventions and Outcome Measures

Arms

Daily oral micronized progesterone

On estrogen replacement therapy using 100mg oral daily micronized progesterone

Etonogestrel implant (Nexplanon)

On estrogen replacement therapy with etonogestrel implant in place

Primary outcome measure

  • Mean change in endometrial thickness after 6 months of progesterone therapy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Julie C Friedman, MD

720-777-2667julie.friedman@cuanschutz.edu

Locations

Childrens Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Julie Friedman, MD

720-777-2667julie.friedman@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • hormone replacement therapy
  • hypogonadism
  • primary ovarian insufficiency
  • endometrial protection
  • progesterone replacement therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-12-06.