Trial Outcomes & Findings for Continuous Versus Cyclical OCP Use in PCOS (NCT NCT03819140)
NCT ID: NCT03819140
Last Updated: 2025-11-14
Results Overview
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 1 month post Yasmin initiation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
measured at baseline and 1 month into therapy
Results posted on
2025-11-14
Participant Flow
Enrollment occurred between April 2019 and January 2022 at the UCSF Center for Reproductive Health's PCOS multidisciplinary clinic.
Participant milestones
| Measure |
Continuous OCP Therapy
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
1 Month on Yasmin
|
21
|
21
|
|
Overall Study
3 Months on Yasmin
|
19
|
19
|
|
Overall Study
6 Months on Yasmin
|
19
|
16
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
| Measure |
Continuous OCP Therapy
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Unable to attend visit(s) due to contracting COVID
|
2
|
1
|
|
Overall Study
Unable to attend visit(s) due to UCSF pandemic policies restricting non-essential visits
|
1
|
3
|
Baseline Characteristics
Continuous Versus Cyclical OCP Use in PCOS
Baseline characteristics by cohort
| Measure |
Continuous OCP Therapy
n=26 Participants
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=25 Participants
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=10 Participants
|
5 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=10 Participants
|
25 Participants
n=10 Participants
|
51 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=10 Participants
|
25 Participants
n=10 Participants
|
51 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
14 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=10 Participants
|
17 Participants
n=10 Participants
|
35 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
26 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=10 Participants
|
25 participants
n=10 Participants
|
51 participants
n=20 Participants
|
|
Serum Total Testosterone
|
32.4 ng/dl
STANDARD_DEVIATION 15.3 • n=10 Participants
|
29.5 ng/dl
STANDARD_DEVIATION 18.5 • n=10 Participants
|
30.97 ng/dl
STANDARD_DEVIATION 16.94 • n=20 Participants
|
|
Modified Ferriman-Gallwey (mFG) score
|
13 units on a scale
STANDARD_DEVIATION 5 • n=10 Participants
|
14 units on a scale
STANDARD_DEVIATION 7 • n=10 Participants
|
13.49 units on a scale
STANDARD_DEVIATION 4.7 • n=20 Participants
|
PRIMARY outcome
Timeframe: measured at baseline and 1 month into therapyPopulation: Analysis exclusions: 1 non-compliant initially with taking continuous dose, 1 unable to promptly obtain yasmin from pharmacy, 1 unresponsive to appointment scheduling reminders, 6 insufficient specimen volume to run assay and unable to calculate change value.
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 1 month post Yasmin initiation.
Outcome measures
| Measure |
Continuous OCP Therapy
n=21 Participants
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=21 Participants
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation
|
-15.38 ng/dl
Standard Deviation 13.15
|
-8.54 ng/dl
Standard Deviation 17.66
|
PRIMARY outcome
Timeframe: measured at baseline and 3 month into therapyPopulation: Analysis exclusions: 3 unable to attend appointment due to COVID, 3 participants elected to drop out of study as desired to switch to another brand of OCP, 3 participants were unresponsive to communications to schedule appointment. 4 contracted COVID or unable to attend visit due to UCSF restriction on non-essential visits during COVID lockdown
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 3 month post Yasmin initiation.
Outcome measures
| Measure |
Continuous OCP Therapy
n=19 Participants
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=19 Participants
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation
|
-17.05 ng/dl
Standard Deviation 17.13
|
-4.58 ng/dl
Standard Deviation 16.46
|
PRIMARY outcome
Timeframe: measured at baseline and 6 month into therapyPopulation: Analysis exclusions (16): 3 voluntarily dropped out of study for personal reasons, 3 unresponsive to appointment scheduling reminders,1 broke fast and unable to draw, 1 specimen hemolyzed and unable to run assay, 4 contracted COVID or unable to attend visit due to UCSF restriction on non-essential visits during COVID lockdown,4 insufficient specimen volume to run 6 month assay and unable to calculate change value.
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 6 month post Yasmin initiation.
Outcome measures
| Measure |
Continuous OCP Therapy
n=19 Participants
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=16 Participants
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation
|
-13.53 ng/dl
Standard Deviation 19.25
|
-9.36 ng/dl
Standard Deviation 13.29
|
SECONDARY outcome
Timeframe: Baseline and at 6 months into therapyPopulation: Analysis exclusions: 8 of the 35 participants who attended the 6 month visit declined the physical exam necessary for physician mFG scoring and thus changes in mFG scores from baseline to 6 months could not be calculated for these participants.
Participants will be examined by a physician and scored using the modified Ferriman-Gallwey Hirsutism score (mFG). This scoring system is considered the standard scoring system that defines hirsutism (excess male pattern hair growth on the body) quantitatively. There are 9 body areas measured on a scare of 0-4, with higher values indicative of significant hair growth. All subscales are combined for a total score, with a minimum score of 0 and max of 36. A total score of \>/=8 is considered diagnostic for hirsutism. The difference in score values from baseline to 6 months was then calculated.
Outcome measures
| Measure |
Continuous OCP Therapy
n=14 Participants
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=13 Participants
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Change in Clinical Findings of Hyperandrogenism - Hirsutism
|
-3.14 numerical change in score on a scale
Standard Deviation 2.85
|
-1.62 numerical change in score on a scale
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: Baseline and at 3 months into therapyDiabetes risk will be assessed and compared in both treatment arms by measuring HOMA-IR (calculated as \[glucose\*insulin\]/405) at both baseline and 3 months visits and calculating the change in HOMA-IR value. Higher HOMA-IR values indicate more severe insulin resistance, with the ranges being as follows: HOMA \<2: Normal, HOMA 2-4: Mild Insulin Resistance, and HOMA \>4: Moderate-Severe Insulin Resistance.
Outcome measures
| Measure |
Continuous OCP Therapy
n=19 Participants
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=19 Participants
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Metabolic Changes With OCP Therapy
|
0.007 HOMA-IR value
Standard Deviation 0.130
|
0.071 HOMA-IR value
Standard Deviation 0.269
|
Adverse Events
Continuous OCP Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cyclical OCP Therapy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous OCP Therapy
n=26 participants at risk
Participants randomly assigned to this arm will receive 8 packs of a 21 day oral contraceptive pills (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which comes in a formulation of 21 days of active hormone and 7 days of sugar pills. In this arm, participants will only be expected to take active hormone pills (colored pills) for the 6 months straight without stopping or taking the sugar pills in each pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
Cyclical OCP Therapy
n=25 participants at risk
Participants randomly assigned to this arm will receive 6 packs of a 21 day oral contraceptive pill (OCP) called Yasmin (3 mg Drospirenone/0.03 mg Ethinyl estradiol) which has 21 days of active hormone and 7 days of sugar pills. Participants will take one pill daily for 6 months and be expected to take the sugar pills at the end of each monthly pack prior to starting a new pack.
Yasmin: Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
|
|---|---|---|
|
Nervous system disorders
Undisclosed Exclusion Criteria - Symptoms and History of Migraines with Aura
|
0.00%
0/26 • 6 months while on Yasmin
|
4.0%
1/25 • Number of events 1 • 6 months while on Yasmin
|
Other adverse events
Adverse event data not reported
Additional Information
Heather Huddleston
University of California, San Francisco
Phone: (415) 353-7475
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place