CONTENTS
October 1996 |
Combined Injectable
Contraceptives The name of combined injectable contraceptives, or CICs, is given to a group of hormonal contraceptives administered by intramuscular injection. The term "combined" indicates that these injectables contain both a progestin and an estrogen. At present there are three main types of CICs on the market:
The first two are new products becoming more widely used throughout the world; the third is mostly used in some Latin American countries. The three formulations provide very effective pregnancy protection for a 30-day period. Therefore they are also referred to as "monthly injectables." CICs have some similarities with progestin-only injectables: the two new CICs contain precisely the same progestin as the two most widely used progestin-only injectables (Depo-Provera and Noristerat); however, the progestin dose received over time is much lower with the new CICs. Although a basic difference from the progestin-only injectables is the presence of estrogen in the CICs, the estrogen was incorporated mostly to improve the control of the menstrual cycle. Both CICs and combined oral contraceptives (COCs) are combined hormonal contraceptives. Besides the different route of administration, from a safety point of view the most important difference is the presence of a "natural" estrogen in the CICs versus a "synthetic" estrogen in the COCs. It is now recognized that natural estrogens have very favorable effects on lipid metabolism and cardiovascular function. The use of natural estrogens in postmenopausal women has actually shown a protective effect against cardiovascular disease, including both cerebrovascular and cardiac problems. Estradiol has direct effects on the arterial wall and on various stages of atherosclerotic plaque formation, resulting in an increase of tissue blood flow and in an anti-atherosclerotic effect. No significant changes in these effects have been found attributable to the addition of a progestin. Based on the above evidence, CICs might actually be considered safer than COCs. However, due to the recent introduction of the two new CICs, no long-term safety information on CIC use is available yet. Therefore, the medical criteria for CIC use are mostly derived from the information existing on COC use.
Q.1. When is the best time to start CICs?If given within the first 7 days of the menstrual cycle, it becomes effective immediately. However, if CICs are started after the first 7 days of a cycle or the woman is not menstruating, a back-up method is recommended to be used for 7 days. Some providers recommend a back-up method be used for 7 days if Cyclofem or Mesigyna are begun after the fifth day of the cycle. Hypothetically, all CICs are effective when begun within the first 7 days of the menstrual cycle. Rationale: Deladroxate is effective immediately when given within the first 7 days of the menstrual cycle and possibly later. Most clinical trials of Cyclofem and Mesigyna (two newer, lower-dose formulations of CICs) have used the first 5 days of the cycle as the period for initiation. However, a recent study has demonstrated high contraceptive efficacy for a CIC similar to Cyclofem and Mesigyna when initiated between days 7 and 10 of the menstrual cycle. Some experts believe that the lower-dose CICs are effective at least as promptly as COCs. These CICs have slightly less estrogen effect and more progestin effect than COCs, and it is presumed that their effect on cervical mucus is at least as prompt as the effect of COCs (46, 152).
Rationale: There are no data on the effects of combined injectables used during lactation. The following rationale is based on what is known about combined oral contraceptives. Even low-dose (30 micrograms) COCs decrease breastmilk production; it may be that estrogen-containing injectables, although they have a lower estrogen dose than COCs, will have a similar effect, but this has not been studied (310, 311).
Rationale: Blood coagulation and fibrinolysis are essentially normalized by 3 weeks postpartum (and are close to normal at 2 weeks postpartum). CICs have minor effects on blood coagulation (51, 98).
Rationale: CICs may be initiated any time after a first- or second-trimester abortion or postseptic abortion (310).
Q.2. When can the next injection be provided?The grace period of combined injectable contraceptives is officially 3 days. If a client comes in after the grace period (27 to 33 days after the previous injection), advise her that delays in obtaining injections increase the risk of pregnancy. Offering re-injection for women who come in after the grace period is reasonable for women who state that, once beyond the grace period, they have been abstaining or consistently using a back-up method and/or the provider can be reasonably sure that the woman is not pregnant. Rationale: Clinical trials have studied the efficacy of CICs given 27 to 33 days after the previous injection and found the efficacy to be very high. Some studies have found that the risk of ovulation is low up to 60 days after the previous Cyclofem or Mesigyna injection (1, 18, 235). Recommendation: There is a risk of in utero exposure to the injectable if she is pregnant when she receives the next injection. However, there is no evidence that fetal exposure to CICs will be harmful. Rationale: Although the estrogens and progestins in CICs have no known teratogenic effects, avoiding the risk of fetal exposure is preferable on general principles (28, 251). Recommendation: It is acceptable to give the injection if you can be reasonably sure she is not pregnant (see How to Be Reasonably Sure the Woman Is Not Pregnant). Some programs will advise women to use a back-up method for the rest of the cycle.
Q.3. If a woman complains of heavier menses and/or |