What does a triphasic oral contraceptive (OC) formulation contain?

From the FDA Drug Label

Kariva® (desogestrel/ethinyl estradiol and ethinyl estradiol tablets USP) provides an oral contraceptive regimen of 21 white, round tablets each containing 0.15 mg desogestrel, 0. 02 mg ethinyl estradiol, Kariva® also contains 5 light-blue, round tablets containing 0. 01 mg ethinyl estradiol, followed by 2 inert light-green, round tablets

The triphasic oral contraceptive formulation contains three phases:

• Phase 1: 21 white tablets with 0.15 mg desogestrel and 0.02 mg ethinyl estradiol
• Phase 2: 5 light-blue tablets with 0.01 mg ethinyl estradiol (no desogestrel)
• Phase 3: 2 inert light-green tablets (no active ingredients) 1

From the Research

A triphasic oral contraceptive formulation contains ethinyl estradiol (0.025-0.040 mg/d) and one of several progestins in doses (0.05-1.0 mg/d) related to their relative potencies, which are substantially lower overall than those in monophasics, as reported in the study by 2. The composition of triphasic oral contraceptives is designed to mimic the natural hormonal fluctuations of a woman's menstrual cycle, with varying doses of estrogen and progestin throughout the 21-day active pill cycle, typically divided into three phases.

• The first phase usually has a lower progestin dose
• The second phase has a moderate dose
• The third phase has the highest dose, while estrogen levels may remain constant or also vary depending on the specific formulation. This approach was developed to minimize side effects like breakthrough bleeding and other hormone-related symptoms while maintaining contraceptive efficacy, as discussed in the study by 3. Some common triphasic formulations include Ortho Tri-Cyclen, which contains ethinyl estradiol combined with norgestimate in three different dose combinations, as mentioned in the example answer. The health benefits of triphasics are similar to those of monophasics and include decreased incidence of unwanted and ectopic pregnancies, ovarian cysts, endometrial and ovarian cancers, benign breast disease, and acute pelvic inflammatory disease, as reported in the study by 2. Triphasic pills are taken daily for 21 days followed by 7 days of placebo pills or no pills, during which withdrawal bleeding typically occurs. The risk-benefit profiles of both triphasics and monophasics are favorable and similar, as stated in the study by 2. It is essential to note that the choice of oral contraceptive should be based on the individual patient's needs and medical history, and the lowest effective dose of estrogen and progestogen should be prescribed, as recommended in the study by 4. In general, menstrual cycle control and side effects are similar in both triphasics and monophasics, but triphasics containing the newer progestins have better cycle control and a reduced incidence of androgenic side effects, as reported in the study by 2. The study by 5 also found that ovarian function is effectively inhibited by a low-dose triphasic oral contraceptive containing ethinylestradiol and levonorgestrel. Additionally, the study by 6 reviewed the literature on a low-dose, extended-cycle combined oral contraceptive pill with continuous ethinyl estradiol, which provides a low-dose, extended-regimen option without sacrificing efficacy or tolerability. However, the most recent and highest quality study, 2, provides the most relevant information on triphasic oral contraceptives.