JOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS 341

Contraceptive Efficacy and Patient Acceptance of Lunelle

Sarah Freeman, PhD, RN, CS, FNP, FAANP

INTRODUCTION

Oral contraceptives (OCs) are the most popular method of reversible birthcontrol in the United States (Abma, Chandra, Mosher, Peterson, & Piccinino,1997; Hillard, 1991); however, their failure rates vary considerably with patientcompliance. With perfect use, the failure rate of combined OCs is 0.1%(Trussell & Kowal, 1998), while typical use is associated with failure rates thatrange from 3% to 8% (Table 1) (Rosenberg & Waugh, 1999). Poor compliancewith OCs and OC discontinuation have serious consequences; together, theyare estimated to account for approximately 20% of all unintended pregnanciesin the United States each year (Rosenberg, & Waugh).

Nuisance side effects, such as nausea, weight gain, mood changes,headaches, and breast tenderness, have been reported to decrease the level ofadherence to OCs, as does the occurrence of breakthrough bleeding or spotting(Rosenberg & Waugh, 1998, 1999). Although it is likely that breakthroughbleeding is both a cause and a consequence of poor compliance, it may leadsome women to believe that an abnormal condition is present, causing them todiscontinue OC use. In addition, the need to take a pill every day in order toachieve optimal protection is a requirement that many women find difficult;despite the knowledge that OC efficacy is largely dependent on daily compli-ance, as many as 74% of patients will miss 1 pill within the first 2 cycles of use.

Long-acting, reversible progestin-only contraceptives (eg, depot medroxy-progesterone acetate [DMPA, Pharmacia Corporation] and levonorgestrelimplants [Norplant, Wyeth Ayerst]) have been developed that eliminate therequirement for daily administration. These methods are associated with fewerunintended pregnancies than OCs (Table 1); however, their side effect profilesmay not be amenable to some women (Abrego de Aguilar et al., 1997). Forexample, they cause menstrual changes ranging from irregular bleeding toamenorrhea, and, with DMPA, the return of fertility may be delayed for overa year. In the case of implants, removal is often more difficult and time-con-suming than initial insertion.

Intrauterine devices (IUDs), particularly progestin-releasing IUDs, alsohave high efficacy rates (Table 1) (Trussell & Kowal, 1998; Sivin & Stern,1994). The Mirena® levonorgestrel-releasing intrauterine system (BerlexLaboratories, Montville, NJ) is the newest IUD of this type in the UnitedStates. Its use is recommended for monogamous women who have had at leastone child and who have never had pelvic inflammatory disease, an ectopicpregnancy, or condition that predisposes to ectopic pregnancy (Mirena®,Berlex Laboratories, 2000).

As a wider array of contraceptive choices becomes available, the number ofunintended pregnancies, as well as abortion rates and pregnancy-related health

PurposeTo review the efficacy, safety, and patientacceptance of the Lunelle™ monthly contra-ceptive injection and to raise awareness of thisnew contraceptive in the United States.

Data SourcesWorldwide scientific literature, reports of clin-ical trials, and manufacturers’ product infor-mation and guidelines.

ConclusionsLunelle™ is a combined hormonal methodwith a safety/tolerability profile comparable tothat of oral contraceptives (OC) and a highefficacy rate and provides a rapid return of fer-tility after discontinuation. Moreover,Lunelle™ was well accepted in a large clinicaltrial, with satisfaction levels similar to those ofnew-start OC users.

Implications for PracticeOral contraceptives are the most popular hor-monal birth control method in the UnitedStates; however, typical use is associated withhigher failure rates than those observed withperfect use because of poor compliance. Poorcompliance has been attributed in part to theneed for daily administration. A new contra-ceptive method that does not require dailyadministration and is readily reversible may besuitable for many women, resulting in betteroverall efficacy.

Key WordsContraception; injection; compliance; fertili-ty; acceptance.

CLINICAL PRACTICE

problems, may decrease. In particular, a new method of contra-ception that does not require daily user compliance may be suit-able to the lifestyles of many women, resulting in better compli-ance and improved contraceptive efficacy. Ultimately, the abilityto match a woman’s reproductive needs with an effective andconvenient contraceptive method should improve outcomes.

A need exists for a simple-to-use, long-acting, easilyreversible contraceptive. Lunelle™ monthly contraceptiveinjection (Pharmacia Corporation, Kalamazoo, MI) is a newcontraceptive option in the United States that eliminates theneed for daily administration, while providing a safety and sideeffect profile similar to that of combination OCs. Lunelle™(MPA/E2C) contains the progestin medroxyprogesteroneacetate (MPA) and estradiol cypionate (E2C), a natural estrogenester that is converted to estradiol (E2) once it enters the blood-stream. Lunelle™ is the first and only once-a-month contra-ceptive injection available in the United States, first marketedhere in October 2000 under the trade name Lunelle. In otherparts of the world, the MPA/E2C contraceptive injection hasbeen available under the trade names Cyclo-Provera andCyclofem since 1993.

The purpose of this review is to describe the efficacy profile

and patient acceptability of MPA/E2C. The pharmacokineticsand clinical trial experience with MPA/E2C are discussed, andthe patient acceptability of MPA/E2C compared with that ofOCs is reviewed.

PHARMACOKINETICS OF MPA/E2C

Several dose-ranging studies were conducted during the1970s to evaluate the efficacy and safety of MPA/E2C in variousdosing combinations (Newton, 1994; Sang et al., 1995; WorldHealth Organization [WHO], 1988). Of the doses studied, thecombination of MPA 25 mg and E2C 5 mg provided the bestefficacy (i.e., complete suppression of ovulation and no preg-nancies) and the most regular bleeding patterns. This formula-tion was chosen for further clinical development. Of note, over-all safety was similar among all doses studied.

The early data regarding the pharmacokinetics of MPA/E2Care limited by the small size and number of studies that wereconducted (Newton, 1994; Sang et al., 1995; WHO, 1988). Inaddition, these studies employed hormonal assay techniques thatare now considered outdated. As a result, two additional studies(Rahimy, Ryan, & Hopkins, 1999; Rahimy, Cromie, Hopkins,& Tong, 1999) were required to gain FDA approval in theUnited States. One of these studies assessed the pharmacokinet-ics of MPA/E2C, while the other assessed the effects of bodyweight and injection site on pharmacokinetics; the results aresummarized below.

The pharmacokinetics of MPA/E2C were evaluated over thecourse of three monthly injections in an open-label, multiple-dose study involving 16 healthy, surgically sterile women(Rahimy, Ryan, et al., 1999). Steady-state concentrations of bothMPA and E2C were achieved after the first injection, with noaccumulation beyond that of the first injection.

The effects of body weight and injection site on the pharma-cokinetics of MPA/E2C were evaluated in a study of 77 healthy,fertile women (Rahimy, Cromie, et al., 1999). Injections weregiven in the arm (n=7), hip (n=23), or leg (n=27); samples werecollected after subjects had received 6 or 7 monthly injections ofMPA/E2C. The results demonstrated that minor differences inMPA pharmacokinetics (due to injection site, body weight, orboth) had no impact on the contraceptive efficacy of MPA/E2C,because trough concentrations (Cmin) were well above thethreshold levels required for ovulation suppression.

CLINICAL EFFICACY OF MPA/E2C

The contraceptive efficacy of MPA/E2C has been establishedin three well-controlled studies (Table 2) sponsored by theWorld Health Organization (Newton, 1994; Sang et al., 1995;WHO, 1988), as well as 21 pharmacologic and 17 supportivephase II and III trials. Taken together, these studies indicate thatMPA/E2C has the highest efficacy of any hormonal contracep-tive (Lunelle™, Pharmacia Corporation, 2000). Overall, theseclinical trials involved more than 17,000 women (representing

342 VOLUME 14, ISSUE 8, AUGUST 2002

AuthorSarah Freeman, PhD, RN, CS, FNP, FAANP, is anAssociate Clinical Professor and Director of the FNP andWHNP Programs at the Nell Hodgson Woodruff Schoolof Nursing, Emory University, Atlanta, GA. Contact Dr.Freeman by e-mail at Sfree0l@emory.edu.

Conflict of Interest StatementThe author is on the speaker panel for PharmaciaCorporation as an expert on all types of injectable contra-ception. This article was written solely for the purpose ofeducating clinicians about a new option in injectable con-traception. The author was not induced by any pharma-ceutical company to write this article.

Table 1. First-year Failure Rates with HormonalContraceptives

Method of hormonal First-year failure rate (%)contraception

Typical use Perfect use

Combined OCs 3-8 0.1

IUDs

Progesterone T 2.0 1.5

Copper T (Gyno-Pharma) 0.8 0.6

Mirena (Berlex) 0.2 0.1

DMPA (Pharmacia) 0.3 0.3

Norplant (Wyeth-Ayerst) 0.05 0.05

Data from Trussell & Kowal, 1998; Rosenberg & Waugh,1999; Sivin & Stern, 1994

JOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS 343

over 145,000 cycles of use), and showed that MPA/E2C was99.9% effective, with a life-table pregnancy rate of 0.1% (PearlIndex=0.09).

A U.S. clinical trial compared the efficacy of MPA/E2C withthat of a currently available OC (Kaunitz, Garceau, & Cromie,1999). This open-label phase III clinical trial enrolled 1,103healthy, sexually active women aged 18 to 48 years. Each womanreceived her choice of treatment with either MPA/E2C (n=782)or norethindrone (NET) 0.5, 0.75, 1.0 mg and ethinyl estradiol(EE) 0.035 mg (NET/EE; Ortho-Novum 7/7/7, Ortho-McNeilPharmaceutical, Raritan, NJ; n=321). The majority of women(55.5% of MPA/E2C users and 67.6% of OC users) completedall thirteen 28-day treatment cycles; the most common reasonfor study discontinuation was that women were lost to follow-up. The results were consistent with those of the earlier WHO-sponsored studies: No pregnancies occurred in the womenreceiving MPA/E2C (representing 8,920 cycles of use), for anoverall pregnancy rate of 0.0%. By comparison, 2 pregnanciesoccurred in the women receiving Ortho-Novum 7/7/7 (repre-senting 3,952 cycles of use), for an overall pregnancy rate of0.3% (Pearl Index=0.4).

RETURN OF FERTILITY

The time to the return of fertility after discontinuation mayinfluence contraceptive selection for some women; therefore,two studies were conducted to determine the time-course ofthe return of fertility in women receiving MPA/E2C. In a studyof MPA/E2C users who had discontinued use to become preg-nant, the fertility rate was approximately 50% six months afterdiscontinuation. Twelve months after discontinuation, the pro-portion of women becoming pregnant increased to 82.9%(Bahamondes et al., 1997). This is comparable to the rate

observed in women who do not use hormonal contraceptives(82%) (Zinaman, Clegg, & Brown, 1996). The time to thereturn of ovulation was assessed in 16 surgically sterile womenwith confirmed ovulatory cycles and regular menstruation whohad received three monthly injections of MPA/E2C. In the 11women who completed the study, ovulation, as assessed byserum progesterone levels, returned promptly, occurring 63 to112 days after the last injection of MPA/E2C (Rahimy &Ryan, 1999).

SAFETY AND TOLERABILITY OF MPA/E2C

Safety experience from the MPA/E2C clinical program isderived from 36 studies of women treated with MPA/E2C con-tinuously for up to 2 years and shows that neither patient age norduration of exposure affects the number or type of adverse events(Lunelle™, Pharmacia Corporation, 2000). In the phase IIIstudies (Newton, 1994; Sang et al., 1995; WHO, 1988), themost common reasons for discontinuation were bleeding-related(i.e., heavy, prolonged, or irregular bleeding and/or spottingoccurring in 1.4% to 24.8% of women) and amenorrhea, whichoccurred in 1.2% to 13.2% of women. Other common reasonsfor discontinuation included headache, dizziness, weight gain orloss (an average weight gain of 1.1 kg was observed in these threestudies), breast tenderness, and backache. Among the 4,268women participating in these studies, there was one report ofunspecified neoplasia, and no changes in cervical cytology werereported.

The U.S.-based comparative study provided further evidenceof the safety and tolerability of MPA/E2C (Kaunitz et al., 1999).Bleeding-related problems (including dysmenorrhea, metrorrha-gia, menorrhagia, and menstrual disorders) were uncommon inthe MPA/E2C and NET/EE groups. Only 6% of MPA/E2C

Table 2. Clinical Efficacy of MPA/E2C

Phase III, WHO-sponsored Studies Phase III, U.S.-based Study

Multinational Egypt China United States(WHO, 1998) (Newton, 1994) (Sang et al., 1995) (Bahamondes et al., 1997)

(n = 1,168) (n = 1,111) (n = 1,955) (n = 782)

Cycles of use* 10,969 10,492 19,765 8,920

Number of pregnancies 0 2 3 0

1-year life-table

pregnancy rate (95% CI) 0 0.2 (0.18, 0.22) 0.1 (0.09, 0.11) 0

Pearl index 0 0.23 (0, 0.51) 0.18 (0, 0.37) 0

* Estimates are used for non-U.S. studies.

WHO=World Health Organization; U.S.=United States; CI=confidence interval.

344 VOLUME 14, ISSUE 8, AUGUST 2002

users and 2% of OC (Ortho-Novum 7/7/7) users discontinueduse related to these bleeding problems. With regard to cycle con-trol, most women treated with MPA/E2C experienced regularmenstrual bleeding lasting for 5 or 6 days and followed by ableeding/spotting-free interval of 21 to 22 days. As would beexpected, bleeding patterns were more predictable in womenreceiving MPA/E2C at regularly spaced intervals.

The U.S.-based study also compared the overall tolerability ofMPA/E2C with that of OCs. Adverse events resulting in studydiscontinuation among MPA/E2C users included weight gain(5.7%), menorrhagia (2.5%), emotional lability (2.5%), andacne (1.9%); the same events occurred in 0.9%, 0.9%, 1.6%,and 0.9% of patients treated with OCs (Kaunitz et al., 1999).The side effect most frequently leading to discontinuation in theMPA/E2C treatment group was weight gain: body weightchanges ranged from 2 lb to 4 lb in women weighing ≤ 150 lband from 3 lb to 8 lb in women weighing > 150 lb. In compar-ison, the women using OCs experienced little or no change inbody weight during the study.

Overall, the type and incidence of adverse events reportedwith MPA/E2C use were consistent with those expected with theuse of combined hormonal OCs. In both treatment groups, theincidence of adverse events was highest in the first three months,and decreased over time (Kaunitz, Garceau, & Cromie, 1999).

PATIENT ACCEPTABILITY: COMPLIANCE PROBLEMSWITH OC USE

As noted earlier, OCs are associated with compliance prob-lems that compromise their high efficacy rates. In actual clinicalpractice, failure rates for OCs are substantially higher (6%) thanthose observed in clinical trials (0.1%). Although 6% may notseem high at first glance, approximately 50% of women willexperience an unintended pregnancy within 10 years at that rate(Hillard, 1992).

The large gap between expected and actual efficacy rates ismost likely related to patient compliance. One study using elec-tronic compliance measuring devices showed that complianceactually worsens with time and that the majority of womenunderestimate their lack of compliance with OCs (Potter,Oakley, de Leon-Wong, & Cañamar, 1996). For example,women miss an average of 1 more pill per month during thethird month of treatment than they did during the first month.Moreover, women seem to be unaware of their lack of compli-ance. When data from the electronic devices were comparedwith that from diary cards completed by the patients, womenhad actually missed an average of 3 times as many pills as theyhad reported on the card. Another report has suggested that asmany as 15% of OC users exhibit poor compliance, leading toan annual failure rate of 7.5% (Rosenberg, Waugh, & Long,1995). To put this into context, this corresponds to approxi-mately 1,000,000 unintended pregnancies each year, or one-third of all pregnancies that occur each year in the United States.

Compliance with OCs clearly has a substantial impact ontheir ability to prevent pregnancy. Why, then, is compliance so

poor? Data from a survey of European women suggest that sev-eral factors contribute to the lack of compliance with OCs: fail-ure to take the pill at the same time every day, failure to read orlack of understanding of the written patient packaging insert,and the lack of adequate instructions from the health careprovider (Rosenberg, Waugh, & Meehan, 1995). Indeed, thesefindings have been confirmed by a U.S. prospective cohort studythat focused on OC compliance and found that 47% of womenmiss 1 or 2 pills per cycle; 22% of women miss 2 or more pillseach month (Rosenberg, Waugh, & Burnhill, 1998).Characteristics associated with poor compliance in the latterstudy included the lack of an established routine for pill-taking,failure to read or lack of understanding of written materials thatcame with the OC package, and the presence of intermenstrualbleeding or spotting.

The same study also used the Patient Reactions Assessment(PRA) to measure patient satisfaction. This instrument quanti-fies the patient’s perception of how well the provider conveyedinformation, the level of care and respect the provider had forthe patient, and how comfortable the patient felt initiating com-munication with the provider. These scores indicated thatwomen were generally satisfied with the level of care theyreceived from their provider (Rosenberg, Waugh, & Burnhill,1998). Satisfaction with the pill, however, was lower amongwomen who reported inadequate counseling from theirproviders. Thus, patient counseling regarding what to expectfrom OCs in terms of efficacy and side effects may improve sat-isfaction and may affect compliance. To date, however, few stud-ies have evaluated the effects of strategies aimed at improvingcompliance (Rosenberg, Waugh, & Meehan 1995).

IMPROVING PATIENT ACCEPTABILITY

Several surveys have been conducted to identify the attribut-es of contraceptive options that appeal to women. In one surveyconducted in Europe, the main suggestion for improvement inOCs was to minimize the frequency of administration, recom-mended by 46% to 62% of respondents (depending on thecountry surveyed) (Fuchs, Prinz, & Koch, 1996). In another sur-vey conducted in a sample of 2,500 women from the UnitedStates, France, Germany, Italy, and Japan, many OC users statedthat although they were content with their current method ofbirth control, there was room for improvement in the contra-ceptive methods available to them (What women want, 1999).Specifically, the frequency of administration and the need tothink about birth control daily were cited as disadvantages toOC use by 31% and 29% of respondents, respectively (Whatwomen want, Roper Starch Worldwide, Inc.). In addition, morethan half (58%) of all women surveyed indicated that theywould prefer a contraceptive that could be taken monthly. Offurther note, a comparable survey was conducted in the UnitedStates in 2000 and provided similar findings (Lunelle: whatwomen want, 2000).

Because patient acceptance correlates with better efficacyrates, the acceptability of monthly injections of MPA/E2C was

JOURNAL OF THE AMERICAN ACADEMY OF NURSE PRACTITIONERS 345

evaluated in a U.S.-based study using three different instru-ments: a User Satisfaction Questionnaire, a TreatmentAssessment questionnaire, and a Global Well-being ScheduleQuestionnaire (Shulman, Oleen-Burkey, & Willke, 1999). Thestudy population included 1,100 women who received theirchoice of either MPA/E2C (n=782) or NET/EE (n=321) for upto 60 weeks of treatment; OC users were further divided basedon prior experience with OCs (i.e., new-start versus previoususers). Questionnaires were administered at baseline, week 20,week 40, week 60, and at study discontinuation.

Questionnaire completion was high: approximately 85% ofwomen completed the final questionnaire (Shulman et al.,1999). Patients in both treatment groups found that their con-traceptive method was not bothersome and did not interferewith their social and daily activities or sexual desire. As a result,over 90% of MPA/E2C users and OC users would recommendtheir chosen method to a friend. Likewise, overall experiencewith the chosen method was favorable and similar for all groupsevaluated: 84.2% of women using MPA/E2C, 86.2% of new-start OC users, and 83.2% of previous OC users. Similarchanges in global well-being were noted in both treatmentgroups. Thus, patient satisfaction with the use of MPA/E2C issimilar to that of OC use.

Although the patient acceptability of MPA/E2C and infre-quent need for administration are expected to improve compli-ance among its users, it should be noted that patient compliancewith injectable contraceptives is by no means perfect. A studyconducted in Africa comparing compliance and use behaviors ofwomen using OCs and DMPA found that approximately one-third of women had forgotten or were unable return to the clinicat the right time for the next injection (Beksinska, Rees,Nkonyane, & McIntyre, 1998). These results emphasize the needto counsel patients about proper use of their chosen method ofbirth control, regardless of the type of contraception chosen.

DOSAGE AND ADMINISTRATION OF MPA/E2C

The recommended dose of MPA/E2C is 0.5 mL. To suppressovulation in the first cycle of use, the initial injection should beadministered within the first 5 days of the onset of a normal men-strual period, within 10 days of a first trimester abortion proce-dure, or between 4 to 6 weeks postpartum (Lunelle™, PharmaciaCorporation, 2000). Thereafter, injections should be adminis-tered monthly (every 28 to 30 days), not to exceed 33 daysbetween injections. The choice of 28- or 30-day intervals is up tothe patient and health care provider, and may be dependent onthe ability of the patient to return to the clinic regularly.

CONCLUSIONS

The clinical experience (both worldwide and in the UnitedStates) with MPA/E2C supports its use as an effective, once-a-month, readily reversible contraceptive. Moreover, MPA/E2Cwas well accepted in the majority of women choosing this

method, with satisfaction levels similar to that of new-start OCusers. Because the contraceptive efficacy of MPA/E2C is notaffected by the site of injection (arm, hip, or leg) or body weightof the patient, no dose adjustment is necessary. Thus, MPA/E2Crepresents a viable first-line contraceptive option and may ulti-mately reduce the number of unintended pregnancies.

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