A Phase 4 interventional study of Yasmin in Polycystic Ovary Syndrome, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to female participants aged 15 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
The mainstay treatment for females with Polycystic Ovary Syndrome (PCOS) has long been a combination of an oral contraceptive pill or OCP (containing both estrogen and progestin) along with an anti-androgen medication (such as Spironolactone) to not only prevent chronic anovulation but also suppress elevated testosterone levels and its clinical effects on the body. While there are multiple OCPs available on the market today and several studies that look at different progestins and their anti-androgenicity, not much is known about whether the length of active pills in OCP therapy (3 weeks versus 6 months) has any further benefit in continued suppression of testosterone and subsequently improvement in clinical findings of hyperandrogenism in the PCOS population. In this pilot randomized open label clinical trial, females between the ages of 16 and 35 years diagnosed with PCOS based on the Rotterdam Criteria, and not currently on medical therapy with an OCP will be enrolled in the study and randomized to either a continuous 6 month OCP or cyclical 21 day active OCP therapy. Our aim is to conduct a pilot randomized clinical trial to determine the effect of 6 months of active monophasic OCPs on testosterone levels and cutaneous findings of hyperandrogenism (hirsutism and acne) as compared to a traditional 21 day active/7 day placebo OCP in women with PCOS. These findings will be compared over a 6 month period.
Those who meet criteria to take part in the study (women between the ages of 16-35 years, diagnosed with PCOS and have findings of hyperandrogenism either by serum testosterone levels above the normal reference range or by their modified Ferriman Gallwey score of >8, and are recommended to start an oral contraceptive pill for therapy) and give consent, will be randomized into either of two oral contraceptive (OCP) treatment groups:
Participants will be given the OCP Yasmin with instructions to take the medication at the same time each day for the length of the study (6 months). On the 4th, 12th and 24th week of therapy (roughly the 1st, 3rd and 6th month), blood work will be drawn and is detailed below.
At 1 month into therapy, (near the end of the 4th week on an OCP) both treatment groups will be expected to get blood work (total and free testosterone, SHBG, estradiol, LH, and FSH levels will be checked). At the time of the blood draw, subjects in the cyclical group should be on placebo/sugar pills and those in the continuous group on active hormone pills.
At 3 months into therapy, participants will come back to the PCOS clinic for routine care follow up and be seen by a Reproductive Endocrinology and Fertility specialist. This visit is considered "standard of care" and not specific to the study. However, during this visit a study investigator will also touch base briefly with the participants to see how they are doing. An online survey (through REDCap) will also be sent to participants that addresses if they have missed any doses of their medication and assess their acne quality of life. In addition, participants will once again get blood work (including total and free testosterone, SHBG, estradiol, LH, FSH, fasting lipid panel, fasting serum glucose, insulin, and HbA1c). As before, the cyclical group should be on placebo/sugar pills at the time of blood draw and the continuous group on active hormone pills.
At 6 months into therapy, participants will come in for a study visit (this is not considered routine care) in which they will have their vitals taken, a physical exam that includes a re-evaluation of their mFG score, and an in-clinic pelvic ultrasound to assess ovarian volume and follicle counts. They will also be emailed a post-study survey through REDCap, that includes a quality of life questionnaire for both acne and hirsutism, and includes questions regarding satisfaction with current therapy and any missed doses of their medication. Lastly, participants will again be expected to get blood work (total and free testosterone, SHBG, estradiol, LH, FSH).
956 studies on the registry are indexed under Polycystic Ovary Syndrome; 176 are open to participants now.
This study's enrollment of 51 is below the median of 70 across 697 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: To be included in this study, participants must be:
Diagnosed with Polycystic Ovary Syndrome based on the 2003 Rotterdam Criteria (must meet 2 out of 3 criteria):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Yasmin
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.
Drug: 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
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 1 month post Yasmin initiation.
Time frame: measured at baseline and 1 month into therapy
Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 3 month post Yasmin initiation.
Time frame: measured at baseline and 3 month into therapy
Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 6 month post Yasmin initiation.
Time frame: measured at baseline and 6 month into therapy
Change in Clinical Findings of Hyperandrogenism - Hirsutism
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.
Time frame: Baseline and at 6 months into therapy
Metabolic Changes With OCP Therapy
Diabetes 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.
Time frame: Baseline and at 3 months into therapy
Enrollment occurred between April 2019 and January 2022 at the UCSF Center for Reproductive Health's PCOS multidisciplinary clinic.
| Milestone | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Started | 26 | 25 |
| 1 month on yasmin | 21 | 21 |
| 3 months on yasmin | 19 | 19 |
| 6 months on yasmin | 19 | 16 |
| Completed | 19 | 16 |
| Not completed | 7 | 9 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Unable to attend visit(s) due to contracting covid | 2 | 1 |
| Withdrew: Unable to attend visit(s) due to ucsf pandemic policies restricting non-essential visits | 1 | 3 |
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 1 month post Yasmin initiation.
| ng/dl | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation | -15.38 ± 13.15 | -8.54 ± 17.66 |
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 3 month post Yasmin initiation.
| ng/dl | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation | -17.05 ± 17.13 | -4.58 ± 16.46 |
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 6 month post Yasmin initiation.
| ng/dl | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation | -13.53 ± 19.25 | -9.36 ± 13.29 |
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.
| numerical change in score on a scale | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Change in Clinical Findings of Hyperandrogenism - Hirsutism | -3.14 ± 2.85 | -1.62 ± 3.36 |
Diabetes 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.
| HOMA-IR value | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Metabolic Changes With OCP Therapy | 0.007 ± 0.130 | 0.071 ± 0.269 |
Collected over 6 months while on Yasmin. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous OCP Therapy | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Cyclical OCP Therapy | 0/25 (0%) | 1/25 (4%) | 0/25 (0%) |
| Event | Continuous OCP Therapy | Cyclical OCP Therapy |
|---|---|---|
| Undisclosed Exclusion Criteria - Symptoms and History of Migraines with AuraNervous system disorders | 0/26 | 1/25 |
| Age, Categorical(Participants) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 26 | 25 | 51 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| Female | 26 | 25 | 51 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 7 | 14 |
| Not Hispanic or Latino | 18 | 17 | 35 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 7 | 5 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 16 | 10 | 26 |
| More than one race | 1 | 6 | 7 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Region of Enrollment(participants) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| United States | 26 | 25 | 51 |
| Serum Total Testosterone(ng/dl) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| Mean | 32.4 ± 15.3 | 29.5 ± 18.5 | 30.97 ± 16.94 |
| Modified Ferriman-Gallwey (mFG) score(units on a scale) | Continuous OCP Therapy | Cyclical OCP Therapy | Total |
|---|---|---|---|
| Mean | 13 ± 5 | 14 ± 7 | 13.49 ± 4.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2019 to primary completion in Oct 2022, 42 months.
Results were first posted in Nov 2025, 3 years after primary completion.
Of 41 non-industry phase 4 interventional studies under Polycystic Ovary Syndrome, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 45. This study's 42 months is above that.
Counting every sponsor, half of 42 studies reached it within 25 months; a quarter within 11 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Drospirenone and ethinyl estradiol combination
University of California, San Francisco →