Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction

NCT02865187 | Completed Results

• 1 other identifier: 6145
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 2

Brief Summary

SUMMARY: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder among reproductive age women with a prevalence as high as 15%. The clinical symptoms of PCOS including menstrual dysfunction, infertility, hirsutism, alopecia, acne, and the possible increased risk of diabetes and cardiovascular disease have been reported to be significant contributors to psychological morbidity and impact health-related quality of life. For women with PCOS, the changes in physical appearance and the associated mood disorders appear to be deleterious for sexual function. Vitamin D deficiency (\<20 ng/ml serum concentration of 25\[OH\]D), which affects from 67% to 85% of women,4 is closely linked to symptoms of PCOS. The main physiologic role of vitamin D is to regulate calcium and phosphorus homeostasis and to promote bone health. Although there has been an increase in awareness of the importance of sexual dysfunction and QoL in women with PCOS, few studies have evaluated the outcomes of treatment for PCOS upon sexual and subjective health status of women. The goals of this study are:

1. 1.To evaluate the prevalence of sexual dysfunction (SDy) in women with Polycystic Ovarian Syndrome (PCOS)
2. 2.To determine the effects of Vitamin D therapy, with and without hormonal contraceptives, on SDy in women with PCOS in the absence of depression.

Conditions

Female Sexual Dysfunction; Polycystic Ovary Syndrome

Keywords

Vitamin D; polycystic ovary syndrome; polycystic ovarian syndrome; PCOS; sexual dysfunction; female sexual dysfunction; low libido

Outcome Measures

Primary Outcomes (1)

• Sexual Function

  Female Sexual Function Index (FSFI) scores at Month 6 (Total score ranges from 2 - 36; scores less than 26.55 represent presence/degree of sexual dysfunction)

  Month 6

Secondary Outcomes (1)

• Prevalence of Sexual Dysfunction in Women With PCOS

  Baseline

Study Arms (2)

Vitamin D + hormonal contraception

EXPERIMENTAL

600IU/day Vitamin D + hormonal contraception

Dietary Supplement: Vitamin D; Drug: Hormonal contraception

Vit D + non-hormonal contraception

ACTIVE COMPARATOR

600IU/day Vitamin D

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D 600IU/day

Vit D + non-hormonal contraception; Vitamin D + hormonal contraception

Hormonal contraception DRUG

Hormonal contraceptives

Vitamin D + hormonal contraception

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Reproductive age
• \. Have diagnosis of polycystic ovary syndrome by Rotterdam criteria (at least 2 of 3 criteria):
• a. Oligomenorrhea (cycles lasting \> 35 days) or amenorrhea (\< 3 cycles in last 6 months)
• b. Clinical signs of hyperandrogenism or elevated total testosterone level
• c. Polycystic appearing ovaries
• \. Report sexual dysfunction
• \. Have no evidence of depression

You may not qualify if:

• \. Has chronic medical illness such as diabetes mellitus, hypertension, and previous venous embolism
• \. Taking any prescription medications for at least 3 months prior to entry into the study with the exception of allergy or occasional pain medications
• \. Has other etiologies of anovulation and hyperandrogenism, e.g., Cushings disease, thyroid dysfunction, elevated prolactin levels, sighs of congenital adrenal hyperplasia
• \. Has any contraindications to hormonal contraception

Sponsors & Collaborators

• Wright State University: lead
• Patty Brisben Foundation For Women's Sexual Health: collaborator

Study Sites (2)

Wright State Physicians

Dayton, Ohio, 45409, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (20)

• Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.

  PMID: 14711538 BACKGROUND

• Norman RJ, Dewailly D, Legro RS, Hickey TE. Polycystic ovary syndrome. Lancet. 2007 Aug 25;370(9588):685-97. doi: 10.1016/S0140-6736(07)61345-2.

  PMID: 17720020 BACKGROUND

• Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and features of the polycystic ovary syndrome in an unselected population. J Clin Endocrinol Metab. 2004 Jun;89(6):2745-9. doi: 10.1210/jc.2003-032046.

  PMID: 15181052 BACKGROUND

• McCook JG, Reame NE, Thatcher SS. Health-related quality of life issues in women with polycystic ovary syndrome. J Obstet Gynecol Neonatal Nurs. 2005 Jan-Feb;34(1):12-20. doi: 10.1177/0884217504272945.

  PMID: 15673641 BACKGROUND

• Barnard L, Ferriday D, Guenther N, Strauss B, Balen AH, Dye L. Quality of life and psychological well being in polycystic ovary syndrome. Hum Reprod. 2007 Aug;22(8):2279-86. doi: 10.1093/humrep/dem108. Epub 2007 May 30.

  PMID: 17537782 BACKGROUND

• Gorwood P. Generalized anxiety disorder and major depressive disorder comorbidity: an example of genetic pleiotropy? Eur Psychiatry. 2004 Feb;19(1):27-33. doi: 10.1016/j.eurpsy.2003.10.002.

  PMID: 14969778 BACKGROUND

• Mansson M, Holte J, Landin-Wilhelmsen K, Dahlgren E, Johansson A, Landen M. Women with polycystic ovary syndrome are often depressed or anxious--a case control study. Psychoneuroendocrinology. 2008 Sep;33(8):1132-8. doi: 10.1016/j.psyneuen.2008.06.003. Epub 2008 Jul 30.

  PMID: 18672334 BACKGROUND

• Kerchner A, Lester W, Stuart SP, Dokras A. Risk of depression and other mental health disorders in women with polycystic ovary syndrome: a longitudinal study. Fertil Steril. 2009 Jan;91(1):207-12. doi: 10.1016/j.fertnstert.2007.11.022. Epub 2008 Feb 4.

  PMID: 18249398 BACKGROUND

• McCluskey SE, Lacey JH, Pearce JM. Binge-eating and polycystic ovaries. Lancet. 1992 Sep 19;340(8821):723. doi: 10.1016/0140-6736(92)92257-g. No abstract available.

  PMID: 1355813 BACKGROUND

• Naessen S, Carlstrom K, Garoff L, Glant R, Hirschberg AL. Polycystic ovary syndrome in bulimic women--an evaluation based on the new diagnostic criteria. Gynecol Endocrinol. 2006 Jul;22(7):388-94. doi: 10.1080/09513590600847421.

  PMID: 16864149 BACKGROUND

• Ching HL, Burke V, Stuckey BG. Quality of life and psychological morbidity in women with polycystic ovary syndrome: body mass index, age and the provision of patient information are significant modifiers. Clin Endocrinol (Oxf). 2007 Mar;66(3):373-9. doi: 10.1111/j.1365-2265.2007.02742.x.

  PMID: 17302871 BACKGROUND

• Janssen OE, Hahn S, Tan S, Benson S, Elsenbruch S. Mood and sexual function in polycystic ovary syndrome. Semin Reprod Med. 2008 Jan;26(1):45-52. doi: 10.1055/s-2007-992924.

  PMID: 18181082 BACKGROUND

• Stovall DW, Scriver JL, Clayton AH, Williams CD, Pastore LM. Sexual function in women with polycystic ovary syndrome. J Sex Med. 2012 Jan;9(1):224-30. doi: 10.1111/j.1743-6109.2011.02539.x. Epub 2011 Nov 14.

  PMID: 22082203 BACKGROUND

• Thomson RL, Spedding S, Buckley JD. Vitamin D in the aetiology and management of polycystic ovary syndrome. Clin Endocrinol (Oxf). 2012 Sep;77(3):343-50. doi: 10.1111/j.1365-2265.2012.04434.x.

  PMID: 22574874 BACKGROUND

• Gur EB, Gokduman A, Turan GA, Tatar S, Hepyilmaz I, Zengin EB, Eskicioglu F, Guclu S. Mid-pregnancy vitamin D levels and postpartum depression. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:110-6. doi: 10.1016/j.ejogrb.2014.05.017. Epub 2014 Jun 2.

  PMID: 24965990 BACKGROUND

• Fernandes de Abreu DA, Eyles D, Feron F. Vitamin D, a neuro-immunomodulator: implications for neurodegenerative and autoimmune diseases. Psychoneuroendocrinology. 2009 Dec;34 Suppl 1:S265-77. doi: 10.1016/j.psyneuen.2009.05.023.

  PMID: 19545951 BACKGROUND

• Wehr E, Pieber TR, Obermayer-Pietsch B. Effect of vitamin D3 treatment on glucose metabolism and menstrual frequency in polycystic ovary syndrome women: a pilot study. J Endocrinol Invest. 2011 Nov;34(10):757-63. doi: 10.3275/7748. Epub 2011 May 24.

  PMID: 21613813 BACKGROUND

• Anglin RE, Samaan Z, Walter SD, McDonald SD. Vitamin D deficiency and depression in adults: systematic review and meta-analysis. Br J Psychiatry. 2013 Feb;202:100-7. doi: 10.1192/bjp.bp.111.106666.

  PMID: 23377209 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Eickman K, Maxwell R, McGinnis LK, Stanczyk F, Legro R, Lindheim SR. Total and bioavailable 25-hydroxyvitamin D is not associated with improved sexual dysfunction following vitamin D supplementation in women with polycystic ovarian syndrome: a pilot study. J Sex Med. 2024 Feb 27;21(3):240-247. doi: 10.1093/jsxmed/qdad176.

  PMID: 38303661 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Sexual Dysfunction, Physiological

Interventions

Vitamin D; Hormonal Contraception

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; 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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Contraception; Reproductive Techniques; Therapeutics

Limitations and Caveats

Participants were allowed to choose their treatment group. There was a large number of lost to follow-up participants.

Results Point of Contact

• Title: Steven R Lindheim
• Organization: Wright State University

doclalalindheim@gmail.com

858-740-1083

Study Officials

• Steven Lindheim, MD

  Wright State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director Reproductive Endocrinology and Infertility

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 12, 2016
• Study Start: February 6, 2017
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 25, 2022
• Results First Posted: October 7, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)