Clinical trial NCT06834594: Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome
Official title: Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome: A Non-randomized Prospective Trial (The BOOST Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Turner Syndrome
Primary Ovarian Insufficiency (Poi)
Keywords: Turner syndrome
Primary ovarian insufficiency
Hormone replacement therapy
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-site open label non-randomized study comparing effects of sequential versus continuous use of progesterone supplementation amongst Turner Syndrome (TS) patients with primary ovarian insufficiency (POI) prescribed hormone replacement therapy (HRT).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Turner Syndrome and Primary Ovarian Insufficiency.
* Prescribed adult dosing\* of transdermal or oral estradiol for estrogen replacement therapy.

  \*Adult dosing of will be defined per published clinical practice guidelines from the 2023 International Turner Syndrome Meeting (i.e. 50-200μg/day of transdermal estradiol, or (i.e. 50-200μg/day of transdermal estradiol or 2-4mg/day oral estradiol).
* Have achieved menarche.

Exclusion Criteria:

* Disclosure of sexual activity and desire for contraception.
* Having a levonorgestrel-releasing intrauterine device or etonogestrel arm implant in place.
* Having received depot medroxyprogesterone within one year prior to study recruitment.
* Non-English or non-Spanish speaking.

Primary outcomes:
measure: Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)
timeFrame: From enrollment to end of treatment at day 90.
Secondary outcomes:
measure: Menstrual distress questionnaire (MEDI-Q)
timeFrame: From enrollment to end of treatment at day 90.
measure: Endometrial thickness.
timeFrame: On study day 90 +/- 14 days.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Kansas City
name: Tazim Dowlut-McElroy, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gravholt CH, Andersen NH, Christin-Maitre S, Davis SM, Duijnhouwer A, Gawlik A, Maciel-Guerra AT, Gutmark-Little I, Fleischer K, Hong D, Klein KO, Prakash SK, Shankar RK, Sandberg DE, Sas TCJ, Skakkebaek A, Stochholm K, van der Velden JA; International Turner Syndrome Consensus Group; Backeljauw PF. Clinical practice guidelines for the care of girls and women with Turner syndrome. Eur J Endocrinol. 2024 Jun 5;190(6):G53-G151. doi: 10.1093/ejendo/lvae050.
citation: Panay N, Anderson RA, Bennie A, Cedars M, Davies M, Ee C, Gravholt CH, Kalantaridou S, Kallen A, Kim KQ, Misrahi M, Mousa A, Nappi RE, Rocca WA, Ruan X, Teede H, Vermeulen N, Vogt E, Vincent AJ; ESHRE, ASRM, CREWHIRL, and IMS Guideline Group on POI. Evidence-based guideline: premature ovarian insufficiency. Hum Reprod Open. 2024 Dec 9;2024(4):hoae065. doi: 10.1093/hropen/hoae065. eCollection 2024.
citation: Dowlut-McElroy T, Kanakatti Shankar R. Hormone Replacement Therapy after Pubertal Induction in Adolescents and Young Adults with Turner Syndrome: A Survey Study. Horm Res Paediatr. 2024;97(1):62-69. doi: 10.1159/000530724. Epub 2023 Apr 24.
citation: Dowlut-McElroy T, Shankar RK. The Care of Adolescents and Young Adults with Turner Syndrome: A Pediatric and Adolescent Gynecology Perspective. J Pediatr Adolesc Gynecol. 2022 Aug;35(4):429-434. doi: 10.1016/j.jpag.2022.02.002. Epub 2022 Mar 8.