Bleeding Patterns in Sequential and Continuous Progesterone Supplementation in Adolescents With Turner Syndrome

Browse trials for

• Turner Syndrome 115
• Primary Ovarian Insufficiency 172

Keywords

• Turner syndrome
• Primary ovarian insufficiency
• Hormone replacement therapy

Study arms

• Active comparator
  Sequential progesterone supplementation

  Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle.

  Drug: Micronized progesterone 200 MG

• Active comparator
  Continuous progesterone supplementation:

  Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.

  Drug: Micronized Progesterone 100 MG

Interventions

• DrugMicronized progesterone 200 MG

  Oral micronized progesterone 200mg for the first 12 days of a 30 to 31-day cycle

  Also known as: Sequential

• DrugMicronized Progesterone 100 MG

  Oral micronized progesterone 100mg daily taken throughout the 30 to 31-day cycle.

  Also known as: Continuous

Primary outcomes

1. Menstrual bleeding patterns as assessed by the Pictorial Bleeding Assessment Chart (PBAC)

   PBAC is one of the most common scoring systems used in the literature to quantify menstrual blood loss (MBL) using a pictorial scoring system, with a higher score representing a larger MBL and a score \>100 qualifying as heavy menstrual bleeding

   Time frame: From enrollment to end of treatment at day 90.

Secondary outcomes

1. Menstrual distress questionnaire (MEDI-Q)

   The Menstrual distress questionnaire (MEDI-Q) is a valid and reliable instrument for the assessment of menstrual distress and its impact on psychological well-being. This tool can be utilized in research and clinical settings to comprehensively investigate the impact of menstruation on various populations

   Time frame: From enrollment to end of treatment at day 90.

2. Endometrial thickness.

   Endometrial thickness measured by transabdominal pelvic ultrasound.

   Time frame: On study day 90 +/- 14 days.

Publications

• 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. PubMed 38748847 ↗
• 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. PubMed 39660328 ↗
• 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. PubMed 37094554 ↗
• 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. PubMed 35272055 ↗

Individual participant data

Plan to share: No — Protect confidentiality of individuals with this rare disease (Turner syndrome).