Clinical trial · Interventional
Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
Evaluation of Vitamin D With and Without Hormonal Contraception on Sexual Function in Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. To evaluate the prevalence of sexual dysfunction (SDy) in women with Polycystic Ovarian Syndrome (PCOS) 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. METHODS: The study will enroll 60 women diagnosed with PCOS and reporting SDy at the Wright State Physicians (WSP) OB-GYN Practice and the WSP Family Medicine Practice. All participants will take vitamin D 600IU/day and will choose between hormonal and non-hormonal contraceptive methods (target of 30 participants in each group). Participants will complete three study visits (Initial, Month 3, and Month 6). Vitamin D levels will be drawn at the beginning of the study and again at 3 and 6 months after initiation of vitamin D therapy. Each participant will be asked to complete the Female Sexual Function Index (FSFI) and the Beck Depression Inventory (BDI) prior to initiation of treatment and again at 6 months.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Female Sexual Dysfunction | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hormonal contraception | Drug | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D + hormonal contraception
- description
- 600IU/day Vitamin D + hormonal contraception
- interventionNames
- Dietary Supplement: Vitamin D
- Drug: Hormonal contraception
- type
- ACTIVE_COMPARATOR
- label
- Vit D + non-hormonal contraception
- description
- 600IU/day Vitamin D
- interventionNames
- Dietary Supplement: Vitamin D
Primary outcomes (1)
- measure
- Sexual Function
- timeFrame
- Month 6
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Reproductive age * 2\. 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 * 3\. Report sexual dysfunction * 4\. Have no evidence of depression Exclusion Criteria: * 1\. Has chronic medical illness such as diabetes mellitus, hypertension, and previous venous embolism * 2\. Taking any prescription medications for at least 3 months prior to entry into the study with the exception of allergy or occasional pain medications * 3\. Has other etiologies of anovulation and hyperandrogenism, e.g., Cushings disease, thyroid dysfunction, elevated prolactin levels, sighs of congenital adrenal hyperplasia * 4\. Has any contraindications to hormonal contraception
References
Publications (20)
- BACKGROUNDRotterdam 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
- BACKGROUNDNorman 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
- BACKGROUNDAzziz 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
- BACKGROUNDMcCook 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
- BACKGROUNDBarnard 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
- BACKGROUNDGorwood 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
- BACKGROUNDMansson 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