Continuous Versus Cyclical OCP Use in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

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:

        1. Ethinyl estradiol 30 mcg-Drospirenone 3 mg (Yasmin): 168 days of active hormone pills
           (no placebo pills) for 6 months.

        2. 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).
    

Intervention name(s): Yasmin
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Drospirenone and ethinyl estradiol combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperandrogenism; Oral Contraceptive Pills