Assessment of Endometrial Thickness Among Adolescent and Young Adult Patients on Estrogen Replacement Therapy Using Daily Oral Micronized Progesterone Versus the Etonogestrel Implant.

NCT06357442 | Recruiting

• 1 other identifier: 23-2305
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean change in endometrial thickness after 6 months of progesterone therapy

  Measure the mean change and variability in endometrial thickness (mm) in AYA treated for 6 months with either the etonogestrel implant or continuous oral progesterone via transabdominal pelvic ultrasound.

  6 months

Secondary Outcomes (1)

• Measure the mean endometrial thickness on estrogen replacement therapy

  At least 3 months on estrogen replacement therapy

Other Outcomes (6)

• Satisfaction of progesterone replacement therapy

  6 months

• Bleeding patterns on progesterone replacement therapy

  6 months

• Side effects of progesterone replacement therapy

  6 months

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes 34 adolescent young adult individuals assigned female at birth, ages 12-25 years with a uterus in place, presenting to Children's Hospital Colorado-affiliated clinics: Pediatric and Adolescent Gynecology Clinic, Endocrine Clinic, Oncofertility Clinic, and Multidisciplinary Turner's Clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Related Publications (16)

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• Stuenkel CA, Davis SR, Gompel A, Lumsden MA, Murad MH, Pinkerton JV, Santen RJ. Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015 Nov;100(11):3975-4011. doi: 10.1210/jc.2015-2236. Epub 2015 Oct 7.

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• Committee Opinion No. 698: Hormone Therapy in Primary Ovarian Insufficiency. Obstet Gynecol. 2017 May;129(5):e134-e141. doi: 10.1097/AOG.0000000000002044.

  PMID: 28426619 BACKGROUND

• Goncalves CR, Vasconcellos AS, Rodrigues TR, Comin FV, Reis FM. Hormone therapy in women with premature ovarian insufficiency: a systematic review and meta-analysis. Reprod Biomed Online. 2022 Jun;44(6):1143-1157. doi: 10.1016/j.rbmo.2022.02.006. Epub 2022 Feb 15.

  PMID: 35461762 BACKGROUND

• Committee Opinion No. 698 Summary: Hormone Therapy in Primary Ovarian Insufficiency. Obstet Gynecol. 2017 May;129(5):963-964. doi: 10.1097/AOG.0000000000002040.

  PMID: 28426614 BACKGROUND

• Effects of hormone replacement therapy on endometrial histology in postmenopausal women. The Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial. The Writing Group for the PEPI Trial. JAMA. 1996 Feb 7;275(5):370-5. doi: 10.1001/jama.1996.03530290040035.

  PMID: 8569016 BACKGROUND

• Lobo RA, Archer DF, Kagan R, Kaunitz AM, Constantine GD, Pickar JH, Graham S, Bernick B, Mirkin S. A 17beta-Estradiol-Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):161-170. doi: 10.1097/AOG.0000000000002645.

  PMID: 29889748 BACKGROUND

• Mueck AO, Romer T. Choice of progestogen for endometrial protection in combination with transdermal estradiol in menopausal women. Horm Mol Biol Clin Investig. 2018 Jul 31;37(2). doi: 10.1515/hmbci-2018-0033.

  PMID: 30063464 BACKGROUND

• Popat VB, Calis KA, Kalantaridou SN, Vanderhoof VH, Koziol D, Troendle JF, Reynolds JC, Nelson LM. Bone mineral density in young women with primary ovarian insufficiency: results of a three-year randomized controlled trial of physiological transdermal estradiol and testosterone replacement. J Clin Endocrinol Metab. 2014 Sep;99(9):3418-26. doi: 10.1210/jc.2013-4145. Epub 2014 Jun 6.

  PMID: 24905063 BACKGROUND

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  PMID: 34274232 BACKGROUND

• "The 2022 Hormone Therapy Position Statement of The North American Menopause Society" Advisory Panel. The 2022 hormone therapy position statement of The North American Menopause Society. Menopause. 2022 Jul 1;29(7):767-794. doi: 10.1097/GME.0000000000002028.

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• Divasta AD, Gordon CM. Hormone replacement therapy and the adolescent. Curr Opin Obstet Gynecol. 2010 Oct;22(5):363-8. doi: 10.1097/GCO.0b013e32833e4a35.

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• Cattoni A, Parissone F, Porcari I, Molinari S, Masera N, Franchi M, Cesaro S, Gaudino R, Passoni P, Balduzzi A. Hormonal replacement therapy in adolescents and young women with chemo- or radio-induced premature ovarian insufficiency: Practical recommendations. Blood Rev. 2021 Jan;45:100730. doi: 10.1016/j.blre.2020.100730. Epub 2020 Jul 4.

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MeSH Terms

Conditions

Primary Ovarian Insufficiency; Hypogonadism

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Julie C Friedman, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 10, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)