Choosing When to Menstruate: The Role of Extended Contraception

1
Choosing When to Menstruate The Role of
Extended Contraception

• Association of Reproductive Health Professionals
• www.arhp.org

2
Expert Medical Advisory Committee

• Linda C. Andrist, PhD, RN-C, WHNP
• Barbara JB Clark, MPAS, PA-C
• Charles Coddington, MD
• Andrew Kaunitz, MD (co-chair)

Required Slide
more
3
Expert Medical Advisory Committee (Continued)

• Sharon Schnare, RN, FNP, CNM, MSN, FAANP
• Lee P. Shulman, MD
• Carolyn L. Westhoff, MD
• Susan Wysocki, RN-C, NP (co-chair)

Required Slide
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Learning Objectives

• Name three health advantages of medically
  reducing menstruation
• Name four types of candidates for extended
  contraceptive regimens
• List four hormonal methods for reducing bleeding
• Describe counseling appropriate for women
  considering use of extended contraceptives

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Frequent Menstruation Is Relatively New
Eaton, SB. Q Rev Biol. 1994.
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Reasons for Increased Frequency
Eaton, SB. Q Rev Biol. 1994.
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Cost to Society of Menstrual Disorders

• Leading U.S. cause of gynecological morbidity
• Cost U.S. industry 8 of total wages
• Women with heavy menstrual flow work 3.6 fewer
  weeks yearly

Cote, I. Obstet Gynecol. 2002. Kjerulff, KH. Am
J Public Health. 1996.Dalton K. Once a Month
Understanding Treating PMS. 1990.
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Regulating Menstruation Health Benefits
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Regulating Menstruation Health Benefits
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Prevention of OC Failures?
Birtch, RL. Contraception. 2006.
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Hormone-free Interval Ovarian Escape
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Initiation of hormone withdrawal symptomson OCP
Estradiol Levels
Initiation of hormone withdrawal symptoms during
spontaneous cycle
0
-7
0
7
14
21
28
Cycle day
Slide courtesy of P. Sulak
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21- vs. 24-day Follicle Development
Sullivan, H. Fertil Steril. 1999.
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21- vs. 24-day Estradiol Levels
Sullivan, H. Fertil Steril. 1999.
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Shorter Pill-free Interval Decreases Follicular
Development

• Randomized double-blind study
• Suppression of ovarian activity more pronounced
  with 23/5 regimen

Spona, J. Contraception. 1996.
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Low Estrogen Doses During the HFI

• Greater ovarian suppression seen with 21/2/5
  regimen

Killick, SR. Am J Obstet Gynecol. 1998.
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Follicular Development in the HFI

• Results Follicular development to an ovulatory
  diameter occurs during HFI

Baerwald, AR. Contraception. 2004.
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Development of Functional Ovarian Cysts

• Results Low-dose OCs have little or no effect on
  development of functional ovarian cysts

Holt, VL. Obstet Gynecol. 2003.
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HFI and Ovarian Activity Conclusions

• Shortening HFI decreases endogenous hormone
  levels
• No significant difference 3 vs. 4 days
• Potential implications for redesign of OCs
• Yaz, Loestrin 24 Fe, Seasonique
• Potential reduction in hormone-withdrawal
  symptoms commonly seen during HFI

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Continuous Use and OC Success
Aubeny, E. Eur J Contracept Reprod Health Care.
2004.
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Continuous Use and OC Success
Aubeny, E. Eur J Contracept Reprod Health Care.
2004.
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Candidates for Reduced Menstruation

• Women with menstrual-related gyn/med disorders
• Adolescents
• Perimenopausal women
• Athletes

more
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Candidates for Reduced Menstruation (Continued)

• Women in the military
• Developmentally delayed women
• Any woman who chooses to bleed less frequently

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Misconceptions About Menstruation
Isnt it natural for me to get a period, even
when Im on the pill?
During my cycle, when am I safe from pregnancy?
During my cycle, when am I safe from
pregnancy?
What is the purpose of monthly bleeding?
Isnt it natural for me to get a period, even
when Im on the pill?
What is the purpose of monthly bleeding?
Is it safe to take hormones to stop my period?
Is it safe to take hormones to stop my period?
ARHP Greenberg Quinlan Rosner Survey 2005.
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ARHP Menstruation Survey Results
ARHP Greenberg Quinlan Rosner Survey 2005.
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Percentage of Women Experiencing Changes
Before/During Their Period
ARHP Greenberg Quinlan Rosner Survey 2005.
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Choice in Menstruation
Health professionals and women ought to view
menstruation as they would any other naturally
occurring but frequently undesirable condition.
This means providing those women who want it with
safe and effective means to eliminate their
menstrual cycles.


Charlotte Ellertson Population Council
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Preferred Frequency of Menstruation
ARHP Greenberg Quinlan Rosner Survey 2005.
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Interest in Changing Menstrual Pattern
Andrist, LC. Contraception. 2004.
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ARHP Providers and Suppression
Andrist, LC. Contraception. 2004.
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Sulak Providers and Suppression
Sulak, PJ. Contraception. 2006.
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Extended OC Regimens Prescribed
Sulak, PJ. Contraception. 2006.
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Instructions Given on How to Extend
Sulak, PJ. Contraception. 2006.
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Perceived Benefits of Menstruation

• Monthly menstruation is
• A natural state
• Necessary for cleansing the system
• Sometimes seen as a symbol of femininity,
  fertility, and youth
• A sign a woman is not pregnant

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There are Many Medical Options for Reducing
Menstruation
Kaunitz, AM. Contraception. 2000.
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Depot Medroxyprogesterone Acetate(Depo-Provera,
Depo-subQ provera 104)
Kaunitz, AM. Am J Obstet Gynecol. 2005. Westhoff,
C. Contraception. 2003. Depo-Provera and
depo-subQ provera 104 PIs.
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Levonorgestrel Intrauterine Device (Mirena)
Kaunitz, AM. Am J Obstet Gynecol. 2005. Hubacher,
D. Obstet Gynecol Surv. 2002. Mirena PI.
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Norethindrone Acetate 5 Mg Tablets (Aygestin)
Irvine, GA. Br J Obstet Gynaecol. 1998.

Aygestin PI.
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Danazol (Danocrine)
Stabinsky, SA. Obstet Gynecol Surv.
1999.Danocrine PI.
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GnRH Analogues (e.g., Leuprolide Acetate, Lupron
Depot)
Stabinsky, SA. Obstet Gynecol Surv. 1999.
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GnRH Analogues
Olive, DL. Treat Endocrinol. 2004. Stabinsky,
SA. Obstet Gynecol Surv. 1999.
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Extended Use of OCs, 19771997
Satisfied with extended use
gt70
Miller, L. Obstet Gynecol. 2001.
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The 21/7 Cycle

• Rock and Pincus designed the pill so that the
  Catholic Church would approve its use
• 3 weeks on / 1 week off to mimic menstruation
• No medical rationale for this decision

Gladwell, M. The New Yorker. 2000.
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Study Extending the Cycle to 49 Days

• Study objective
• Compare 28-day vs. 49-day cycle
• Look for differences in bleeding pattern,
  symptoms, hygiene product use, and overall
  satisfaction

Miller, L. Obstet Gynecol. 2001.
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Patients Completing 28- v. 49-day RCT
Miller, L. Obstet Gynecol. 2001.
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Bleeding, Spotting in 28- or 49-day Cycle

• No significant differences in amenorrhea,
  frequent menses, or prolonged menses
• Prolonged bleeding (gt10 days) occurred in 3 women
  on 21/7 regimen and 2 women on 42/7 regimen

Miller, L. Obstet Gynecol. 2001.
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Actual vs. Expected Bleeding
Miller, L. Obstet Gynecol. 2001.
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Days of Hygiene Product Use over Study
Miller, L. Obstet Gynecol. 2001.
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Cost of Hygiene Products
(Plt0.001)
Miller, L. Obstet Gynecol. 2001.
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Summary Extending to 49 Day Regimen
Satisfaction score
Miller and Notter. Obstet Gynecol 2001.
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RCT of a 91-day Extended Cycle OC (Seasonale)
Compared to
Anderson, FD. Contraception. 2003.
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On-treatment Pregnancies
Anderson, FD. Contraception. 2003.
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Days of Unscheduled Bleeding/Spotting
Anderson, FD. Contraception. 2003.
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Unscheduled Bleeding Over Time
Anderson, FD. Contraception. 2003.
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Endometrial Changes After 1 Year

• Endometrium quickly reverted to normal cyclic
  changes after discontinuation
• Suggests there no adverse effect on the
  endometrium

Anderson, FD. Contraception. 2005.
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Summary of 91-day Extended OC Trial

• Results
• Extended regimen as effective in preventing
  pregnancy as conventional OCs
• Withdrawal bleeding is comparable
• Frequency of unscheduled bleeding episodes
  initially higher with extended regimen but
  declines over time
• No endometrial pathology noted
• Nonmenstrual side effects are comparable

Anderson, FD. Contraception. 2003.
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Extended Use with Seasonique

• Overall failure rate 1.27 (Pearl index)
• Cycle control and safety similar to those
  reported for other OC regimens

Anderson, FD. Contraception. 2006.
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6-month Continuous vs. Conventional
Kwiecien, M. Contraception. 2003.
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Conclusion Continuous vs. Conventional

• Satisfaction with regimen was high and similar in
  both groups
• Appealing option for many women

Kwiecien, M. Contraception. 2003.
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Continuous OCs 12-cycle RT

• Comparison of bleeding profiles 21/7 vs.
  continuous schedule

Miller, L. Obstet Gynecol. 2003
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No Bleeding or Hygiene Product Use
Miller, L. Obstet Gynecol. 2003
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Summary 12-cycle RT, Continuous OCs
Miller, L. Obstet Gynecol. 2003
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Summary 12-cycle RT, Continuous OCs
Miller, L. Obstet Gynecol. 2003
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Continuous Triphasic OC Retrospective Chart
Review
Shulman, L. Contraception. 2005.
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Yasmin Study
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Foidart, J-M. Contraception. 2006.
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Reduction in BTB Over Time
Foidart, J-M. Contraception. 2006.
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Hormones and Continuous OCs

• Study question are bleeding patterns dependent
  on the hormones given?
• RCT, 180 days, 4 arms
• 139 women enrolled

Edelman, AB. Obstet Gynecol. 2006.
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Percent Women Amenorrheic for 30 Days
Edelman. AB. Obstet Gynecol. 2006.
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Conclusion Continuous OCs and Bleeding Patterns

• In continuous users, NETA OCs are associated with
  less bleeding than LNG OCs

Edelman, AB. Obstet Gynecol. 2006.
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Dedicated Continuous and Extended Use Options
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Other Potential Options for Extending

• Contraceptive vaginal ring (NuvaRing?)
• Approved for contraceptive use October 2001
• Transdermal contraceptive patch (Ortho Evra?)
• Approved for contraceptive use November 2001

Bjarnadottir, RI. Am J Obstet Gynecol.
2002. Zieman, M. Fertil Steril. 2002.
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Extended Regimens of Vaginal Ring (NuvaRing)
Miller, L. Obstet Gynecol. 2005
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Bleeding/Spotting Days with the Ring
Miller, L. Obstet Gynecol. 2005
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Extended Use of the Transdermal Patch (Ortho
Evra)
Compared to
Stewart. FH. Obstet Gynecol. 2005.
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Bleeding/Spotting Days with Traditional vs.
Extended Patch Regimen
Stewart, FH. Obstet Gynecol. 2005.
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Estrogen-withdrawal Headaches
LaGuardia, KD. Fertil Steril. 2005.
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Extended Use of Patch or Ring vs. OCs
but

• Clinical significance unclear
• Studies are being conducted to assess if this
  represents a greater risk for VTE

Ortho Evra Web site. van den Heuvel, MW.
Conrtraception. 2005. Jick, SS. Contraception.
2006.
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Concerns Extended Use of Patch or Ring

• Risk of blood clots higher with pregnancy than
  with hormonal methods
• More data needed to better define safety of
  extended use regimens with patch and ring

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Patient Counseling Introducing Extended Regimen
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Patient Counseling Safety

• A growing body of data offers reassurance on the
  safety of extended regimens

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Patient Counseling Advantages

• Alleviate menstruation-related conditions
• May reduce some side effects
• Convenience
• Less need for hygiene products

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Patient Counseling Disadvantages

• Unpredictability
• Remembering the schedule
• Detecting a pregnancy
• Cost

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Patient Counseling Instructions for Use

• Hormone-free days, if at all
• Schedule of method

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Patient Counseling What to Expect

• Spotting
• Blood color and texture

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Patient Counseling When to Contact Provider

• Heavy bleeding
• Nausea with vomiting
• Bloating
• Severe headaches
• Mood changes
• Suspect pregnancy
• Any signs or symptoms

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Extended Hormonal Contraception Conclusions

• Many women would prefer to menstruate less
• A variety of hormone therapies/delivery systems
  can be used to reduce menstruation
• Extended hormonal regimens may help improve
  quality of life in many groups of women

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Recommendations
Educate providers about regulating
menstruation Improve counseling of patients
Increase awareness and knowledge of women about
menstruation and the option of extended
contraception
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• Appendix

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Expert Medical Advisory Committee
Linda Andrist, PhD, RNC, WHNPAssociate
Professor, Graduate Program in Nursing MGH
Institute of Health ProfessionsBoston, MA
Barbara Clark, MPAS, PA-CAAPA LiaisonGalesburg,
IL
Charles Coddington, MDMayo Clinic Chair,
Reproductive Medicine Professor of Obstetrics
and GynecologyMayo Medical School Rochester, MN
more
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Expert Medical Advisory Committee (Continued)
Andrew Kaunitz, MD (co-chair)Professor and
Assistant ChairmanUniversity of Florida Health
Sciences Center Jacksonville, FL
Sharon Myoji Schnare RN, FNP, CNM, MSN,
FAANPClinical Instructor Department of Family
and Child Nursing University of Washington
Seattle School of Nursing Olalla, WA
Lee P. Shulman, MDNorthwestern Memorial
Hospital Distinguished Physician and Professor
Department of Obstetrics and Gynecology Feinberg
School of Medicine Northwestern
University Chicago, IL
more
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Expert Medical Advisory Committee (Continued)
Carolyn Westhoff, MD, MScProfessor of Ob/Gyn and
Public HealthColumbia University Medical
CenterNew York, NY
Susan Wysocki, RN-C, NP (co-chair)President and
CEONational Association of Nurse Practitioners
in Womens Health (NPWH) Washington, DC