Trial · NCT02865187
Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
NCT02865187, Not applicable, Completed, Wright State University; results first posted 2021-10-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction. Trials, record NCT02865187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02865187
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction
- NCT number
- NCT02865187
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- Wright State University
- Conditions
- Female Sexual Dysfunction, Polycystic Ovary Syndrome
- Interventions
- Vitamin D, Hormonal contraception
- First posted
- 2016-08-12
- Last updated
- 2022-03-25
- Results first posted
- 2021-10-07
- Limitations and caveats
- Participants were allowed to choose their treatment group. There was a large number of lost to follow-up participants.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sexual Function | Month 6 | 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) |
| Secondary | Prevalence of Sexual Dysfunction in Women With PCOS | Baseline | Prevalence rate of women with PCOS defined by scores of the FSFI (total scores range from 2-36; scores less than 26.55 represent presence/degree of sexual dysfunction) - For this outcome, total scores were converted, using the cutoff score of 26.55, into a dichotomous variable for presence or absence of sexual dysfunction. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sexual Function | Month 6 | score on a scale | MEAN | |
| SECONDARY | Prevalence of Sexual Dysfunction in Women With PCOS | Baseline | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sexual Function | Vitamin D + Hormonal Contraception | 24.8 | Standard Deviation 7.6 | score on a scale | |
| Sexual Function | Vit D + Non-hormonal Contraception | 26.0 | Standard Deviation 4.7 | score on a scale | |
| Prevalence of Sexual Dysfunction in Women With PCOS | Vitamin D + Hormonal Contraception | 26 | Participants | ||
| Prevalence of Sexual Dysfunction in Women With PCOS | Vit D + Non-hormonal Contraception | 11 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vitamin D + Hormonal Contraception | 33 | |
| Overall Study | STARTED | Vit D + Non-hormonal Contraception | 14 | |
| Overall Study | Visit 2 - at 3 Months | Vitamin D + Hormonal Contraception | 23 | |
| Overall Study | Visit 2 - at 3 Months | Vit D + Non-hormonal Contraception | 7 | |
| Overall Study | COMPLETED | Vitamin D + Hormonal Contraception | 20 | |
| Overall Study | COMPLETED | Vit D + Non-hormonal Contraception | 7 | |
| Overall Study | NOT COMPLETED | Vitamin D + Hormonal Contraception | 13 | |
| Overall Study | NOT COMPLETED | Vit D + Non-hormonal Contraception | 7 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | worsening depression | Psychiatric disorders | Vitamin D + Hormonal Contraception | 1 | 23 | 1 |
| other | worsening depression | Psychiatric disorders | Vit D + Non-hormonal Contraception | 0 | 7 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vitamin D + Hormonal Contraception | 0 | 23 |
| Total, all-cause mortality | Vit D + Non-hormonal Contraception | 0 | 7 |
| Total, other adverse events | Vitamin D + Hormonal Contraception | 1 | 23 |
| Total, other adverse events | Vit D + Non-hormonal Contraception | 0 | 7 |
| Total, serious adverse events | Vitamin D + Hormonal Contraception | 0 | 23 |
| Total, serious adverse events | Vit D + Non-hormonal Contraception | 0 | 7 |
Source ClinicalTrials.gov
Papers20
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vitamin D + Hormonal Contraception vs Vit D + Non-hormonal Contraception: Prevalence of Sexual Dysfunction in Women With PCOS | Trial comparisons |
| Vitamin D + Hormonal Contraception vs Vit D + Non-hormonal Contraception: deaths from any cause | Trial comparisons |
| Vitamin D + Hormonal Contraception vs Vit D + Non-hormonal Contraception: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02865187
GET https://conductscience.org/api/trials/v1/NCT02865187/registered