A woman's contraceptive needs change as she transitions through the various stages of the reproductive lifespan. As an adolescent and young woman, she requires a highly efficacious method to prevent pregnancy. In her active childbearing years, she requires a method that allows her to space her children. And after she has completed childbearing and in the perimenopausal years, she again needs an effective method to prevent pregnancy, as well as to ease her transition through the menopause.

Important characteristics of contraceptives that influence a patient's choice of a particular method during these various life stages include efficacy, safety, convenience, ability to prevent sexually transmitted diseases, reversibility, discreteness, cost, and coverage by an insurance company.

A Roper Starch Worldwide poll conducted in 1999 suggests that 63% of Italian women, 33% of Japanese women, 59% of French women, 46% of German women, and 53% of US women would consider new contraceptive alternatives. This same worldwide poll found that 91% of women say the ideal contraceptive would be easy to use, 87% say it would have few or no side effects, 58% say it would be taken monthly, and 54% say it would allow a rapid return of fertility after discontinuation.

This symposium will focus on the latest option in contraception: the first monthly combination injectable contraceptive, marketed as Lunella internationally and as Lunelle in the United States. This contraceptive contains 25 mg of medroxyprogesterone acetate and 5 mg of estradiol cypionate. It shares many of the benefits of other long-term contraceptive methods (efficacy and convenience), as well as of oral contraceptives (cycle control, rapid return to fertility, and a comparable side-effect profile). These attributes will likely make the combination monthly injectable an attractive contraceptive option to a wide range of women.

Lunella/Lunelle is the first monthly combination injectable contraceptive. It contains 25 mg of medroxyprogesterone acetate (MPA) and 5 mg of estradiol cypionate (E2C), and has been studied clinically for the past 35 years and tested in more than 7,000 women worldwide.

This monthly injectable contraceptive offers a number of significant advantages to patients over other currently available methods: It is highly effective, maintains regular monthly cycles, is rapidly reversible, and confers few adverse metabolic effects.

Absorption of MPA and E2C continues for several days post-injection. E2C levels peak at 200 pg/ml around day 2 after injection and decline over the next 28 days, returning to baseline levels (around 100 pg/ml) by day 14. Pharmacokinetic studies reveal that MPA levels remain above 400 pg/ml for 35 days after injection. Monthly injections confer sufficient MPA levels to effectively suppress ovulation for around 42 days. Steady-state levels are achieved after the first injection, and there is no further accumulation of either hormone.

In studies conducted by the World Health Organization between 1984 and 1990, the injectable combination contraceptive had a 0% failure rate per 100 woman-years based on 10,969 woman-months of use. No serious adverse events were attributed to MPA/E2C use, and nuisance side effects were reported by a minority of patients. Discontinuations for bleeding irregularities were infrequent.

Return to fertility after discontinuation of MPA/E2C was comparable to the rate seen with oral contraceptives and other long-term methods, with a 12-month pregnancy rate slightly above 80%.

A US Phase III study comparing the injectable contraceptive Lunelle (25 mg medroxyprogesterone acetate, 5 mg estradiol cypionate, MPA/E2C) to the oral contraceptive (OC) Ortho-Novum 7/7/7 (0.035 mg ethinyl estradiol, 0.5/0.75/1.0 mg norethindrone) was conducted in the United States at 42 investigational sites. The trial was open-label, controlled, and nonrandomized. All subjects were sexually active and desiring contraception, aged 18 to 49 years, and willing to rely on one of the two offered methods for at least 60 weeks.

Participants were allowed to choose the contraceptive method they would use during the study. Seven hundred and eighty-two patients chose the monthly combination injectable and 321 patients chose the OC.

The first injection of MPA/E2C was given within 5 days of the onset of menses. Subsequent injections were repeated every 28 days+5 days.

The 1-year failure rate for the injectable was 0% versus 0.34% for the OC.

Bleeding patterns were more regular than expected: MPA/E2C users had regular menses after the first cycle of use. In addition, the average cycle interval was 28 days, with a 5- to 6-day bleeding episode followed by a 21- to 22-day bleeding-free episode. Surprisingly, rates of breakthrough bleeding were lower in injectable than OC users. In addition,1% of the injectable users experienced amenorrhea during the first month of use; 4% experienced amenorrhea by 60 weeks

Adverse events were similar in the two groups. However, MPA/E2C users experienced a median increase of 4 lbs. during seven cycles of use, and 5 lbs. over 15 cycles of use. Heavier women tended to gain more weight than women weighing <150 lbs. Weight was generally unchanged among OC users.

In contrast with OC users, participants using MPA/E2C experienced no increase in triglyceride levels. No other significant laboratory changes were observed in either group.

Women of all reproductive ages and socioeconomic strata may be appropriate candidates for use of the new monthly combination injectable. However, patient education and management are critical to continuing and satisfied use of this method.

The recommended dose of medroxyprogesterone acetate/estradiol cypionate (MPA/E2C) is 0.5 ml given intramuscularly into the deltoid, anterior thigh, or gluteus maximus muscle. The aqueous solution must be vigorously shaken before injection to ensure uniform suspension of the hormone crystals.

The injection can be given within 5 days of the onset of a normal menstrual period. It may also be administered within 10 days of a first-trimester abortion or between 4 and 6 weeks postpartum. Subsequent injections should be given within 28 to 30 days of the preceding injection, and no sooner than 23 days and no later than 33 days. Women who miss a dose should be advised to use a barrier method of contraception and be evaluated for pregnancy prior to receiving the next injection.

Contraindications to MPA/E2C use include pregnancy; breast or endometrial cancer; a current or past history of thromboembolism or other cerebral, vascular, or coronary artery diseases; cholestatic jaundice of pregnancy or jaundice with prior hormone contraceptive use; and undiagnosed abnormal genital bleeding. Women over the age 35 years who smoke should also not receive the monthly combination injectable.

Patients should be counseled about the need to return on a monthly basis for injection; this visit needn't be scheduled with a physician, as a nurse or pharmacist in many countries may be able to administer the injection. Patients should be educated about possible estrogen/progestin-related side effects and how to handle them, as well as potential drug interactions. In addition, they should be advised that MPA/E2C injections may prove to provide the noncontraceptive health benefits of oral contraceptives.

Questionnaires administered during the Phase III US trial suggest that patient acceptance of the monthly injectable combination contraceptive containing medroxyprogesterone acetate/ estradiol cypionate (MPA/E2C) is high. Indeed, patient attitudes and perceptions of the method are comparable to those of women starting on oral contraceptives (OCs) for the first time.

In the US trial, 90% of MPA/E2C users rated their overall satisfaction with the method as "somewhat to very favorable." Fifty-five percent of MPA/E2C users were comfortable with the administration of the contraceptive and 79% were not bothered by the injection. A wide majority of all subjects in the study reported that the method did not interfere with their social or daily activities, and >90% of women in both the injectable and OC groups said they would recommend their method to a friend. Eighty-seven percent of the participants said they experienced no difficulty in making scheduled visits to the physician for repeat injections.

Worldwide polls suggest that a number of women in many countries would be interested in using the monthly combination injectable method. Challenges for increasing usage include widening access, developing a subcutaneous formulation that will allow patients to self-administer the contraceptive, and distinguishing MPA/E2C from depot medroxyprogesterone acetate injections.

Copyright 2000 Foundation for Better Health Care

Used with permission.

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Faculty
Moderator
Anita L. Nelson, MD
Professor, Department of Obstetrics and Gynecology
David Geffen School of Medicine at UCLA
Medical Director, Women’s Health Care Programs
Harbor-UCLA Medical Center
Torrance, California
 

Participants
Kurt Thomas Barnhart, MD, MSCE
Associate Professor
Department of Obstetrics and Gynecology
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania

Brad Davidson, PhD
Account Director
MBS/Vox
A CommonHealth Company
Wayne, New Jersey

Susan Kellogg-Spadt, CRNP, PhD
Director of Sexual Medicine
The Pelvic & Sexual Health Institute
Philadelphia, Pennsylvania

Felicia Hance Stewart, MD
Adjunct Professor
Department of Obstetrics, Gynecology, and Reproductive Sciences
Co-Director
UCSF Center for Reproductive Health Research & Policy
University of California, San Francisco
San Francisco, California

Anthony Tizzano, MD
Staff Obstetrician and Gynecologist
Cleveland Clinic Women’s Health Center at Wooster
Wooster, Ohio

CME Information
Overall Goal
The overall goal of this monograph is to educate clinicians about how to broach possibly taboo subjects such as sex, the vagina, and vaginal administration of medication with patients.

Needs Assessment
Through needs assessment surveys, literature searches, advisory board suggestions, and previous meeting evaluations and market research, The Foundation for Better Health Care (FBHC) has determined a need to address clinician-patient interactions about sex, the vagina, and vaginal drug administration.

Intended Audience
This FBHC is designed for obstetrician/gynecologists and nurse practitioners who care for reproductive-age women needing contraception.

Learning Objectives
The FBHC supports the recent Institute of Medicine’s recommendations that "All healthcare professionals should be educated to deliver patient-centered care as members of an interdisciplinary team, emphasizing evidence-based practice, quality improvement approaches and informatics."¹

Upon completion of this continuing medical education activity, participants should have improved overall knowledge, skills, and attitudes in discussing and prescribing vaginally administered medication. Specifically, participants should be able to:

Clinical recommendations are based upon evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications to care for patients.

The in-office linguistic study was performed to gain a better understanding of how clinicians and patients discuss contraception in general and vaginally inserted contraception in particular. The study included 45 visits with patients of childbearing age (average 31 years) with 14 ob/gyns (nine male and five female) and three nurse-practitioners. The visits represented a range of typical interactions (21 annual exams, seven 6-month check-ups, eight first-postpartum visits, and nine for various health complaints). The average length of each visit was 9 minutes and 32 seconds (range: 2 minutes to 29 minutes and 13 seconds); of that time, 42%, or roughly 4 minutes, was spent discussing contraception. The visits were video- and audio-taped, and patients and clinicians were interviewed separately after the visit.

The visits and interviews were then transcribed and analyzed applying sociolinguistic models. Findings indicate that, while physicians and patients discuss the vaginal contraceptive ring, the manner in which they do so reveals an underlying difficulty with the topic that prevents the ring from being considered as a serious birth-control option. There are, however, simple conversational strategies that can be employed that will ease many of the difficulties encountered when discussing the ring.

Patterns of Avoidance
Despite the fact that the vaginal contraceptive ring was discussed in nearly half of the visits, none of the women in the study selected the ring as their birth-control method (see Table 1). "The content and tone of the presentation of vaginal delivery creates a barrier to further communication about the vaginal contraceptive ring, which essentially shuts down any real discussion of its appropriateness for a given patient," said Dr. Davidson. Patterns of conversation that were observed in these visits showed typical effects of discussing a taboo subject. "Discussing the vagina, even in medical settings, remains a fairly robust taboo in practice," he said. "Linguistically, approaching taboo subjects creates what is called ‘a face-threatening event’ for both patients and clinicians."

He noted that "rational actors seek to avoid face-threatening events"² unless there is a compelling reason to overcome the potential for social or linguistic breach. "When the benefits of breaking a taboo outweigh the social pressures to maintain the taboo intact, which is the situation with things like pelvic exams and colonoscopies, physicians routinely override their patients’ desires to avoid talking," he said. "They find ways of making it clear this is something we need to discuss this. This is the approach that people could be taking with vaginal delivery methods, but right now, they’re not."

To provide perspective on how taboos affect discourse, Dr. Davidson cited several studies showing patterns of avoidance in other types of sexually related clinical discussions. Clinicians’ reasons for avoiding sexually explicit talk in these visits included fear of embarrassing the patient, a perceived lack of training, and insufficient communication skills.^3-5

Speaking to the issue of avoidance, Dr. Davidson noted that both this study and previous research⁵ have found that clinicians and patients don’t often use the word "vagina", regardless of the setting. For example, in the MBS/Vox study, the word was used in only 16 of 45 visits; of 38 uses of the word, 37 were by clinicians and only one was by a patient. "Given that these were visits with gynecologists, which often included physical exams and detailed discussions of gynecologic issues, the fact that the word ‘vagina’ isn’t used anywhere in about two-thirds of the conversations is really striking," he said.

In addition, clinicians and patients in the current study were more likely to engage in discussions of the contraceptive patch than of the ring. While the patch and the ring were both mentioned in numerous visits (31 vs. 22, respectively), 15 patients asked questions about the patch after it was presented, and only two asked questions about the ring. "So the ring is mentioned, but then it’s just dropped as a topic," he said. This pattern of conversational avoidance is typical of other taboo subjects, such as sexual function and death and dying. "Taboo as a term from anthropology doesn’t mean ‘bad,’ it means too big to speak about directly, either because something is sacred or profane or both. In all cases, knowing what’s taboo and how to avoid it is something that is deeply ingrained in a culture. Flaunting a taboo without first being clear why you’re doing so doesn’t necessarily erase the taboo, it may simply make people uncomfortable and make you appear out of touch."

Terms for Female Genitalia
By definition, taboo subjects don’t have a good vocabulary developed around them that allow people to talk about them easily. Because these topics are consistently avoided, when the time comes and you need to talk about them, the words aren’t there.

Because of the taboo, women are more likely to use "oblique and disconnected language" when talking about their bodies than are men. ⁶ While a multitude of terms exist for female genitalia that can be categorized as either anatomical, coy, euphemistic, or vulgar, none of them is truly appropriate for an open discussion of medical issues.⁷ "It’s this lack of appropriate and accepted ways of talking that creates the basic problem, more than the idea that people are saying the wrong thing about vaginally inserted medications--but that the right thing exists if only they knew what it was," he said. "You have to negotiate a conversation like this carefully."

Conversational Strategies
Dr. Davidson noted that when dealing with face-threatening events, clinicians display five typical conversational strategies, "all of which minimize the involvement of the speakers in the taboo, either by postponing the discussion or by framing it as something strange" (see Tables 2 and 3).

Distancing
Doctor: It’s an easy thing to do, they even have a ring that you put in once a month. You know, if you’re inclined to put a ring in your vagina.

Patient: Ok.

Delay and Distancing
Doctor: Now, you’re interested in going back on contraception?

Patient: Yes.

Doctor: Now there are new things out.

Patient: Yes. Okay.

Doctor: Okay. In addition to the pill, we have a patch…

Patient: Okay.

Doctor: Which is once a week. And, we also have the NuvaRing, which is once a month. You have to place it in the vagina.

Patient: Ehh.

Doctor: And not many people are interested in that.

Avoidance
Doctor: There’s no rubber dam in between. It’s just the ring—you would put it inside the vagina and leave it for 3 weeks and then take it out for the 4^th week so that you could have a menstrual cycle, and then put a brand new ring back in.

Patient: Nods head (yes).

Depersonalization
Doctor: Now they’ve got: the patch, which is the same as the birth control pill, only it’s absorbed through the skin; and the ring, which is the same as the birth control pill, except for it’s absorbed through the vaginal mucosa…

Tuning
Doctor: Uh, it’s a little flexible, thin ring that most people just—you don’t know it’s there once you insert it…

Patient: Oh, my god!

Doctor: …And then, at the end of the three weeks you take it out…

Patient: Mm-hmm…

Doctor: …You can go ahead, sit up… Some people just don’t like the

idea; they feel kind of squeamish about using a vaginal ring…

Patient: Mm-hmmm… Yeah.

Doctor: …It just doesn’t sound like something they’d be comfortable with,

uh, or they’re worried that they’ll feel it during intercourse, but…

Patient: Uh-huh…

Doctor: …You know, you’re doing so well with the pill otherwise. As long as you could…

_________________________________________________________________________________________

"These strategies exist to allow physicians to discharge their clinical obligation to be thorough and present the vaginal ring, while at the same time allowing them to ensure that the social relationship with the patient isn’t threatened," he said. For example, in response to the patient’s reaction of "Oh, my god!" in the example of ‘Tuning,’ the physician both acknowledges that the topic is shocking ("…feel kind of squeamish") without directly implicating the patient ("some people", not "you").

"A lot of this behavior happens well below the level of conscious manipulation," he said. "People don’t choose to say ‘the vagina’ instead of ‘your vagina,’ they just do, but when you see a consistent pattern of impersonal reference like that, it’s a good diagnostic for revealing what topics are taboo in a society. If you knew nothing about our culture but read these transcripts, you would be able to identify this as a subject people generally avoid talking about."

The overall effect of this pattern of avoidance in the study was that discussions of the vaginal contraceptive ring were short, and the conversations moved quickly on to other methods of contraception. "If you consider all methods of birth control equally appropriate for everyone, then you are going to talk less about the one that is challenging socially," he noted. This can be seen in the excerpt below, where both the transdermal patch and the vaginal ring are presented as possible topics for discussion, but where the talk quickly returns to the patch once the patient displays reluctance to pursue the ring further:

Patient: Yeah, I’ve heard of that [the patch]! Is it just as effective?

Doctor: Oh it’s all the same effectiveness, absolutely. And it’s just as good as far as getting your fertility back after going off of it. There’s also a vaginal ring that goes into your vagina that you keep it in for 3 weeks and take it out for a week.

Patient: Okay.

Doctor: It’s a little plastic ring…you don’t look like you’re too thrilled about that.

Patient: No.

Doctor: The patch …you would want to probably stay on it, you know, until the end of the year. Then go off of it and start trying.

Referencing Medication Benefits
Dr. Davidson concluded his presentation by giving advice on how best to overcome the taboo and encourage the use of vaginal insertion for the delivery of medications. "The important thing is to first recognize that this is a difficult topic to approach and that there is going to be some push back from the patient, and second, to find a way of addressing the patient’s discomfort without simply letting the topic drop."

Dr. Davidson cautioned that "There is no one right way for a clinician to talk with patients about taboo subjects. Each clinician needs to find a way of approaching the subject that they are comfortable with and that makes it appropriate in the context of the general discussion." Rather than attempting to confront and change the taboo about the vagina directly, Dr. Davidson suggested that discussions about the vaginal ring and other vaginally administered products may often best be initiated by referencing the benefits of the medication, rather than the route of delivery. "Don’t start with the difficult issue. Start by presenting why you think this is a good option, either because of steady delivery rates or some other benefit. Then, once you’ve established why this is a good option, addressing the mode of delivery will be a natural extension of the conversation." He also suggested that, once a clinician decides to talk about the route of delivery via the vagina, he or she should acknowledge to the patient that this is not an easy topic to discuss, rather than pretend they are discussing any other route of administration.

Finally, Dr. Davidson pointed out that most physicians are already experienced in discussing difficult subjects. "Every ob/gyn knows how to talk to patients about difficult or delicate subjects, and how to overcome patients’ initial reluctance to discuss certain issues. Physicians are uniquely positioned, socially, to talk about things people wouldn’t talk about otherwise. Tapping into that experience is what will help physicians talk about the vaginal contraceptive ring."

References
1. MBS/VOX: Creating a New Conversation Around NuvaRing^®. Managing the Dialogue™ --Summary. October 10, 2003. Organon USA, on file.

2. Brown P, Levinson S. Politeness: Some Universals in Language Usage. Cambridge, United Kingdom: Cambridge University Press; 1987.

3. Verhoeven V, Bovijn K, Helder A, Peremans L, et al. Discussing STIs: Doctors are from Mars, patients from Venus. Fam Prac 2003;20:11-15.

4. Press Y, Menahem S, Shvartzman P. Sexual dysfunction—what is the primary physician’s role? Harefuah 2003;142:662-665,719.

5. Weijts W, Houtkoop H, Mullen P. Talking delicacy: Speaking about sexuality during gynaecological consultations. Soc Health Illness 1993;15:295-313.

6. Jackson S. Different decade, same shit. Trouble & Strife 1999;39:30-40.

7. Braun V, Kitzinger C. Snatch, "hole," or "honey-pot?" Semantic categories and the problem of nonspecificity in female genital slang. J Sex Res 2001;146-158.

Copyright 2004 Foundation for Better Health Care

Used with permission.

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