RECRUITING

Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?

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Conditions

Polycystic Ovary SyndromePuberty DisordersOvulation DisorderPCOSovulationpubertyhyperandrogenemiaandrogen excess

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Adolescent girls with androgen excess have a higher rate of irregular periods and decreased ovulation rates compared to normal girls, and are considered at-risk for developing polycystic ovary syndrome (PCOS). This pilot study will look at whether giving spironolactone might improve ovulation rates in girls with androgen excess, ages 13-19. If this is true, spironolactone treatment to young girls might prevent PCOS from developing and avoid future infertility.

Official Title

Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?

Quick Facts

Study Start:2019-12-18
Study Completion:2024-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04075149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years to 19 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Girls age 13 - 19 years, with clinical or biochemical HA (defined as hirsutism and/or elevated Tanner stage-specific free testosterone concentrations) that are 4-6 years post-menarche
  2. * Screening labs within age-appropriate normal range
  3. * Volunteers who are 18-19 y old must be willing and able to provide written informed consent.
  4. * When the subject is a minor (i.e., age \< 18 y), the subject and custodial parents must be willing and able to provide written informed assent and consent, respectively.
  5. * Willingness to strictly avoid pregnancy (using non-hormonal methods) during the time of study.
  1. * Age \< 13 or \> 19 y
  2. * Girls ≤ 3 years and ≥ 7 years post-menarche will be excluded
  3. * Being a study of androgen excess in adolescent girls with HA, men and boys are excluded
  4. * Inability to comprehend what will be done during the study or why it will be done
  5. * Precocious puberty (breast development before age 7)
  6. * Primary amenorrhea (no menses by age 16)
  7. * BMI-for-age \< 5th percentile
  8. * Patients currently enrolled in another research protocol will be excluded, except for those enrolled in IRB-HSR 17633 DENND1A
  9. * Obesity due to genetic syndrome (e.g. Prader-Willi syndrome)
  10. * Cushing syndrome
  11. * Positive pregnancy test or lactation. Subjects with a positive pregnancy test will be informed of the result by the screening physician. Under Virginia law, parental notification is not required for minors. However, the screening physician will encourage them to tell their parent(s) and counsel them about the importance of appropriate prenatal care and counseling. We will arrange follow-up for them at the Teen Health Clinic at the University of Virginia or their primary care physician's office in a timely manner.
  12. * Diabetes mellitus
  13. * History of congenital adrenal hyperplasia or 17-hydroxyprogesterone \> 300 ng/dL in the follicular phase, which suggests the possibility of congenital adrenal hyperplasia. NOTE: If a 17-hydroxyprogesterone \> 300 ng/dL is confirmed on repeat testing, and ACTH-stimulated 17-hydroxyprogesterone \< 1000 ng/dL will be required for study participation.
  14. * Total testosterone \> 150 ng/dL
  15. * Abnormal thyroid stimulating hormone (TSH) for age. Subjects with adequately treated hypothyroidism, reflected by normal TSH values, will not be excluded.
  16. * Abnormal sodium, potassium, or bicarbonate concentrations, or elevated creatine concentration (confirmed on repeat)
  17. * Subjects must not take exogenous steroids or any medications known to affect the reproductive axis or glucose metabolism for 3 months prior to the study (or in the 2 months prior to screening). Such medications include oral contraceptives, progestins, metformin, glucocorticoids, and antipsychotic medications
  18. * If sexually active, subjects will be required to abstain and/or use barrier forms of contraception during the study.

Contacts and Locations

Study Contact

Melissa Gilrain, BS
CONTACT
434-243-6911
pcos@virginia.edu
Christine Burt Solorzano, MD
CONTACT
434-243-6911
pcos@virginia.edu

Principal Investigator

Christine Burt Solorzano, MD
PRINCIPAL_INVESTIGATOR
University of Virginia

Study Locations (Sites)

University of Virginia Center for Research in Reproduction
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Christine Burt Solorzano, MD, PRINCIPAL_INVESTIGATOR, University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-18
Study Completion Date2024-09-01

Study Record Updates

Study Start Date2019-12-18
Study Completion Date2024-09-01

Terms related to this study

Keywords Provided by Researchers

  • PCOS
  • Polycystic Ovary Syndrome
  • ovulation
  • puberty
  • hyperandrogenemia
  • androgen excess

Additional Relevant MeSH Terms

  • Polycystic Ovary Syndrome
  • Puberty Disorders
  • Ovulation Disorder