Study Highlights

• 700 women aged 35 years or younger seeking OCP use at an urban family planning clinic were randomly assigned to receive either 3 or 7 cycles of OCPs.
• Exclusion criteria were contraindications to hormonal contraceptives, hormonal contraceptive use in the past 7 days, desiring pregnancy in the next 6 months, not sexually active, not English- or Spanish-speaking, and plans to leave the area within 6 months.
• 359 women were randomly assigned to receive 3 cycles.
• 341 women were randomly assigned to receive 7 cycles.
• 661 women participated.
• Women were assigned to groups by age and insurance status.
• 19% of participants were younger than 18 years and received OCPs as packs: 42 received 3 cycles, and 43 received 7 cycles.
• 64% of participants were aged 18 years and older without insurance and received OCPs as packs: 165 received 3 cycles, and 159 received 7 cycles.
• 17% of participants were aged 18 years and older with insurance and were randomly assigned to receive packs or prescription for refills: 25 received packs and 28 received prescriptions in the 3-cycle group; 16 received packs and 26 received prescriptions in the 7-cycle group.
• All women received 1 free pack of OCPs for initial use and a supply of condoms.
• All women received routine care, including emergency contraception during the visit, if indicated.
• The healthcare provider selected the OCP from the 2 available types: 35 µg ethinyl estradiol and 0.18/0.215/0.25 mg norgestimate, or 25 µg ethinyl estradiol and 0.18/0.215/0.25 mg norgestimate.
• Patients who received 3 cycles were scheduled for a routine 3-month follow-up visit.
• Patients who received 7 cycles did not have a scheduled follow-up.
• The 7-cycle vs 3-cycle group was more likely to have given birth and to have at least 2 children.
• Most participants were Hispanic.
• 504 of 661 participants were interviewed by telephone 6 or more months after enrollment: 260 in the 3-cycle group and 244 in the 7-cycle group.
• OCP continuation was defined as OCP use in the past 7 days or by number of packs started and completed.
• The primary outcome measure was 6-month OCP continuation within each group.
• Follow-up data were obtained from 76% of participants (260/342 in the 3-cycle group, and 244/319 in the 7-cycle group).
• The 6-month OCP continuation rate was higher for the 7-cycle vs the 3-cycle group (51% vs 35%; P < .001).
• The effect of 7-cycle vs 3-cycle OCP use on 6-month continuation rates was greater for participants younger than 18 years (49% vs 12%; P < .001) vs for those 18 years of age or older (52% vs 40%; P = .018).
• Receiving prescription vs packs was linked with a lower rate of 6-month continuation overall (21% vs 42%; P = .027) in both the 3-cycle group (21.4% vs 56.0%) and the 7-cycle group (42.3% vs 50.0%), based on limited data and small sample size.
• 6 adverse events occurred in the 3-cycle group: ectopic pregnancy, syncope, upper respiratory infection, asthma exacerbation, gastroenteritis, and ulcerative colitis flare-up.
• 3 adverse events occurred in the 7-cycle group: cholecystectomy, hemiplegic migraine, and gastroenteritis.
• Pregnancies occurred in 25 (9.9%) of 260 women in the 3-cycle group and 22 (9.0%) of 244 women in the 7-cycle group.
• The most common reasons for discontinuation of OCPs were adverse effects, ran out of pills, not sexually active, missed pills, and seeking pregnancy.
• Discontinuation of OCP as a result of running out of pills was more common in the 3-cycle vs the 7-cycle group (42/168 vs 16/119 women who discontinued use; P = .02).
• Study limitations included lack of generalizability to other populations and limited power to compare effects of pack vs prescription supply because of the small subgroup size.