Trial Outcomes & Findings for Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction (NCT NCT02865187)

NCT ID: NCT02865187

Last Updated: 2022-03-25

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: Month 6
• Results posted on: 2022-03-25

Participant Flow

Participant milestones

Measure	Vitamin D + Hormonal Contraception 600IU/day Vitamin D + hormonal contraception Vitamin D: Vitamin D 600IU/day Hormonal contraception: Hormonal contraceptives	Vit D + Non-hormonal Contraception 600IU/day Vitamin D Vitamin D: Vitamin D 600IU/day
Overall Study STARTED	33	14
Overall Study Visit 2 - at 3 Months	23	7
Overall Study COMPLETED	20	7
Overall Study NOT COMPLETED	13	7

Reasons for withdrawal

Measure	Vitamin D + Hormonal Contraception 600IU/day Vitamin D + hormonal contraception Vitamin D: Vitamin D 600IU/day Hormonal contraception: Hormonal contraceptives	Vit D + Non-hormonal Contraception 600IU/day Vitamin D Vitamin D: Vitamin D 600IU/day
Overall Study Lost to Follow-up	12	7
Overall Study Adverse Event	1	0

Baseline Characteristics

Evaluation of Vitamin D in Women With PCOS and Sexual Dysfunction

Baseline characteristics by cohort

Measure	Vitamin D + Hormonal Contraception n=33 Participants 600IU/day Vitamin D + hormonal contraception Vitamin D: Vitamin D 600IU/day Hormonal contraception: Hormonal contraceptives	Vit D + Non-hormonal Contraception n=14 Participants 600IU/day Vitamin D Vitamin D: Vitamin D 600IU/day	Total n=47 Participants Total of all reporting groups
Age, Continuous	28.2 years STANDARD_DEVIATION 5.6 • n=5 Participants	32.2 years STANDARD_DEVIATION 5.1 • n=7 Participants	29.5 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	14 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	10 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	14 participants n=7 Participants	47 participants n=5 Participants
Female Sexual Function Inventory (FSFI)	19.6 score on a scale STANDARD_DEVIATION 8.3 • n=5 Participants	22.8 score on a scale STANDARD_DEVIATION 4.6 • n=7 Participants	20.5 score on a scale STANDARD_DEVIATION 7.5 • n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Vitamin D + Hormonal Contraception n=23 Participants 600IU/day Vitamin D + hormonal contraception Vitamin D: Vitamin D 600IU/day Hormonal contraception: Hormonal contraceptives	Vit D + Non-hormonal Contraception n=7 Participants 600IU/day Vitamin D Vitamin D: Vitamin D 600IU/day
Sexual Function	24.8 score on a scale Standard Deviation 7.6	26.0 score on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Vitamin D + Hormonal Contraception n=33 Participants 600IU/day Vitamin D + hormonal contraception Vitamin D: Vitamin D 600IU/day Hormonal contraception: Hormonal contraceptives	Vit D + Non-hormonal Contraception n=14 Participants 600IU/day Vitamin D Vitamin D: Vitamin D 600IU/day
Prevalence of Sexual Dysfunction in Women With PCOS	26 Participants	11 Participants

Adverse Events

Vitamin D + Hormonal Contraception

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vit D + Non-hormonal Contraception

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vitamin D + Hormonal Contraception n=23 participants at risk 600IU/day Vitamin D + hormonal contraception Vitamin D: Vitamin D 600IU/day Hormonal contraception: Hormonal contraceptives	Vit D + Non-hormonal Contraception n=7 participants at risk 600IU/day Vitamin D Vitamin D: Vitamin D 600IU/day
Psychiatric disorders worsening depression	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/7 • 6 months

Additional Information

Steven R Lindheim

Wright State University

Phone: 858-740-1083

Email: doclalalindheim@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place