Polycystic Ovary SyndromePhase 4CCOUPNCT03819140

Continuous Versus Cyclical OCP Use in PCOS

A Phase 4 study testing Yasmin in people with Polycystic Ovary Syndrome, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 15 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Polycystic Ovary Syndrome
What is being tested?: Yasmin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2019to 16 Oct 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 40 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

None listed.

Who cannot join

Females with Polycystic Ovary Syndrome (PCOS) who do not have either biochemical (elevated total or free testosterone levels) or clinical (modified Ferriman-Gallwey hirsutism score <8) findings of hyperandrogenism will not be included in the study as this is one of the primary outcome measures.
Females with PCOS who are already on and currently using a form of contraceptive (oral, vaginal ring, or patch)
Females that are concurrently using or plan to use an anti-androgenic medication such as Spironolactone in the next 6 months.
Females currently or are planning to obtain permanent hair removal (ex. laser hair removal, electrolysis) in the concurrent 6 months of starting oral contraceptive (OCP) therapy will also be excluded from the study
Women who are pregnant or have contraindications for starting an OCP, including active smokers, history of clotting disorders, history of deep vein thrombosis or blood clots, neoplasia, vascular disease, migraines, hypertension, or have renal/hepatic disease will be excluded from the study as OCP therapy would not be indicated or approved in this population.
Females with elevated potassium levels above the normal reference range for age.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94158

Other trials in United States

About this study

Official title: Continuous Versus Cyclical OCP Use in PCOS: A Pilot Study

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.

Read the detailed description

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:

Ethinyl estradiol 30 mcg-Drospirenone 3 mg (Yasmin): 168 days of active hormone pills (no placebo pills) for 6 months.
Ethinyl estradiol 30 mcg-Drospirenone 3mg (Yasmin): 21 days of active + 7 days of placebo pills for 6 months

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).

Conditions: Polycystic Ovary Syndrome
Being tested: Yasmin
Keywords: Hyperandrogenism, Oral Contraceptive Pills
Medical subject headings: Polycystic Ovary Syndrome, Hyperandrogenism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

YasminDrug
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.

Study groups in NCT03819140
Study group	Role	What they receive
Continuous OCP Therapy	Active comparator	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. Receives: Drug: Yasmin
Cyclical OCP Therapy	Active comparator	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. Receives: Drug: Yasmin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: measured at baseline and 6 month into therapy

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline and at 3 months into therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201916 Oct 2022

First posted28 Jan 2019
Study start1 Apr 2019
Primary completion16 Oct 2022
Study completion16 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03819140
Sponsor's protocol ID: 18-24705
Acronym: CCOUP
Status last verified: Oct 2025
First submitted: 29 Nov 2018
Last updated: 14 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Legro RS, Pauli JG, Kunselman AR, Meadows JW, Kesner JS, Zaino RJ, Demers LM, Gnatuk CL, Dodson WC. Effects of continuous versus cyclical oral contraception: a randomized controlled trial. J Clin Endocrinol Metab. 2008 Feb;93(2):420-9. doi: 10.1210/jc.2007-2287. Epub 2007 Dec 4.
PubMed 18056769

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Active, not recruitingObservational study
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Not yet recruitingObservational study
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All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Continuous Versus Cyclical OCP Use in PCOS: A Pilot Study
ClinicalTrials.gov ID: NCT03819140
Acronym / sponsor ID: CCOUP / 18-24705
Conditions: Polycystic Ovary Syndrome
Keywords: Hyperandrogenism, Oral Contraceptive Pills
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 16 Oct 2022 (actual)
Study completion: 16 Oct 2022 (actual)
First posted: 28 Jan 2019 (actual)
Results: Posted 14 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Ethinyl estradiol 30 mcg-Drospirenone 3 mg (Yasmin): 168 days of active hormone pills (no placebo pills) for 6 months.
Ethinyl estradiol 30 mcg-Drospirenone 3mg (Yasmin): 21 days of active + 7 days of placebo pills for 6 months

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Continuous OCP Therapy	Active comparator	Drug: YasminParticipants 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.
Cyclical OCP Therapy	Active comparator	Drug: YasminParticipants 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.

Who may qualify

Ages: 15 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (6 listed)

Females with Polycystic Ovary Syndrome (PCOS) who do not have either biochemical (elevated total or free testosterone levels) or clinical (modified Ferriman-Gallwey hirsutism score <8) findings of hyperandrogenism will not be included in the study as this is one of the primary outcome measures.
Females with PCOS who are already on and currently using a form of contraceptive (oral, vaginal ring, or patch)
Females that are concurrently using or plan to use an anti-androgenic medication such as Spironolactone in the next 6 months.
Females currently or are planning to obtain permanent hair removal (ex. laser hair removal, electrolysis) in the concurrent 6 months of starting oral contraceptive (OCP) therapy will also be excluded from the study
Women who are pregnant or have contraindications for starting an OCP, including active smokers, history of clotting disorders, history of deep vein thrombosis or blood clots, neoplasia, vascular disease, migraines, hypertension, or have renal/hepatic disease will be excluded from the study as OCP therapy would not be indicated or approved in this population.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
YasminParticipants 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.	Drug	Continuous OCP Therapy, Cyclical OCP Therapy

Primary outcome

Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation
Time frame: measured at baseline and 1 month into therapy
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 1 month post Yasmin initiation.
Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation
Time frame: measured at baseline and 3 month into therapy
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 3 month post Yasmin initiation.
Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation
Time frame: measured at baseline and 6 month into therapy
Positive or negative change in blood serum Total Testosterone value (units: ng/dl) from baseline to 6 month post Yasmin initiation.

2 secondary outcomes

Change in Clinical Findings of Hyperandrogenism - Hirsutism
Time frame: Baseline and at 6 months into therapy
Metabolic Changes With OCP Therapy
Time frame: Baseline and at 3 months into therapy

Results and safety

Results posted to the registry on 14 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous OCP Therapy	26	19
Cyclical OCP Therapy	25	16

Primary outcome: Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation

Time frame: measured at baseline and 1 month into therapy. Mean (Standard Deviation). Unit: ng/dl

Measure	Continuous OCP Therapy n = 21	Cyclical OCP Therapy n = 21
Value	-15.38 (13.15)	-8.54 (17.66)

Population analysed: 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.

Primary outcome: Change in Biochemical Hyperandrogenism From Baseline to 3 Month Post Yasmin Initiation

Time frame: measured at baseline and 3 month into therapy. Mean (Standard Deviation). Unit: ng/dl

Measure	Continuous OCP Therapy n = 19	Cyclical OCP Therapy n = 19
Value	-17.05 (17.13)	-4.58 (16.46)

Population analysed: 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

Primary outcome: Change in Biochemical Hyperandrogenism From Baseline to 6 Month Post Yasmin Initiation

Time frame: measured at baseline and 6 month into therapy. Mean (Standard Deviation). Unit: ng/dl

Measure	Continuous OCP Therapy n = 19	Cyclical OCP Therapy n = 16
Value	-13.53 (19.25)	-9.36 (13.29)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months while on Yasmin. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous OCP Therapy	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Cyclical OCP Therapy	1 of 25 (4%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18056769Legro RS, Pauli JG, Kunselman AR, Meadows JW, Kesner JS, Zaino RJ, Demers LM, Gnatuk CL, Dodson WC. Effects of continuous versus cyclical oral contraception: a randomized controlled trial. J Clin Endocrinol Metab. 2008 Feb;93(2):420-9. doi: 10.1210/jc.2007-2287. Epub 2007 Dec 4.
Individual participant dataSharing planned: No

Related trials for Polycystic Ovary Syndrome

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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
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Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather Huddleston, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Yasmin in people with Polycystic Ovary Syndrome, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Biochemical Hyperandrogenism From Baseline to 1 Month Post Yasmin Initiation (time frame: measured at baseline and 1 month into therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03819140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.