Long-Term Reversible Contraception:

A dialogue among Andrew M. Kaunitz, MD, David A. Grimes, MD, and Anita L. Nelson, MD, held on

October 29, 2006

Audio Accompaniment

FacultyAndrew M. Kaunitz, MD (Chair)

Professor and Assistant Chairman Department of Obstetrics and Gynecology

University of Florida College of Medicine-Jacksonville Jacksonville, Fla

David A. Grimes, MD Vice President of Biomedical Affairs

Family Health International Clinical Professor

Department of Obstetrics and Gynecology University of North Carolina School of Medicine

Chapel Hill, NC

Anita L. Nelson, MD Professor

Department of Obstetrics and Gynecology David Geffen School of Medicine

University of California Los Angeles (UCLA) Medical Director

Women’s Health Care Programs Harbor-UCLA Medical Center

Los Angeles, Calif

Landscape of reversible long-term

contraception• The contraceptive landscape in the US is continuing to change

• Several options are currently available– Copper T IUD– Levonorgestrel-releasing IUS– Single-rod progestin-only implant

IUD=intrauterine device; IUS=intrauterine system

IUDs and implants currently available in

the United States

*Data suggest that this device may be effective for up to 7 years. NA=not available. Adapted from Peterson HB et al. N Engl J Med. 2005; 353:2169-2175.

First year failure rates of

contraceptives (typical use)

DMPA=depot medroxyprogesterone acetate. *Estimate in lieu of actual data.Trussell J. Contraception. 2004;70:89-96. **Funk S et al. Contraception. 2005;71:319-326.

Single-rod etonogestrel

(progestin)-releasing implant

• Implantable contraception has recently returned to US

• Highly effective, convenient, long-acting method of contraception

• Provides “insert it and forget it” contraceptive efficacy for up to 3 years

Copper T IUD

• FDA recently liberalized package labeling for the copper T IUD– Nulliparous and multiparous women now deemed

appropriate candidates– Restrictive language regarding a history of pelvic

inflammatory disease has been removed

• Highly effective, convenient IUD• Approved for up to 10 years of use

Levonorgestrel-releasing IUS

• New reports of off-label noncontraceptive applications of levonorgestrel-releasing IUS– Effective for menorrhagia, including that

associated with fibroids1-6 – Efficacy for symptoms of uterine adenomyosis7

– Comparable GnRH-a for symptomatic pelvic endometriosis8

GnRH-a=gonadotropin-releasing hormone agonist; IUS=intrauterine system. 1. Grigorieva V et al. Fertil Steril. 2003;79:1194-1198. 2. Marjoribanks J et al. Cochrane Database Syst Rev. 2003;(2):CD003855. 3. Soysal S et al. Gynecol Obstet Invest. 2005;59:29-35. 4. Hurskainen R et al. JAMA. 2004;291:1456-1463. 5. Inki P et al. Ultrasound Obstet Gynecol. 2002;20:381-385. 6. Reid PC et al. BJOG. 2005;112:1121-1125. 7. Fedele L et al. Fertil Steril. 1997;68:426-429. 8. de Sa Rosa e Silva AC et al. Fertil Steril. 2006;86:742-744.

Contraception and compliance

• Compliance is difficult with contraception that requires daily attention

• Need to move toward “forgettable” contraception

• All 3 methods being discussed provide highly effective contraception without the attendant risks and irreversibility of sterilization

Use of IUDs: contraception and beyond

• Many progestin-releasing IUDs are placed off-label for noncontraceptive benefits– Treating menorrhagia, including that associated

with uterine fibroids

• Patients can achieve their goals– Long-term, highly effective, convenient birth

control– Treatment of heavy bleeding without an invasive

and irrevocable surgical procedure

Case 1: Contraception and relief of menorrhagia

• Busy 29-year-old lawyer with 6-month-old child

• Thinking of becoming pregnant again in several years

• Heavy menstrual flow and an irregular but not grossly enlarged uterus on bimanual exam

• Ultrasound reveals several small intramural fibroids

Contraceptive options that reduce menorrhagia

• Oral contraceptives or DMPA– Oral contraceptives make periods shorter and more

predictable– Amenorrhea often results with long-term injectables

• Extended-cycle rings or pills might be difficult with a busy lifestyle

• Single-rod etonogestrel-releasing implant is characterized by erratic spotting and bleeding

• Copper T IUDs lead to increased menstrual blood loss

• A progestin-releasing IUD makes sense for a woman with baseline menorrhagia

Use of a progestin-releasing IUD for

treatment of menorrhagia• Effective in women with fibroids and normal uterine

cavities1-3

• One report also showed promising results in women with uterine cavities distorted by submucosal fibroids4

• A few small intramural fibroids should not present a problem with insertion

1. Grigorieva V et al. Fertil Steril. 2003;79:1194-1198. 2. Hurskainen R et al. JAMA. 2004;291:1456-1463. 3. Inki P et al. Ultrasound Obstet Gynecol. 2002;20:381-385. 4. Soysal S et al. Gynecol Obstet Invest. 2005;59:29-35.

Important tips when inserting an IUD

• Do not open IUD package until you:– Confirm patient’s desire to proceed with insertion– Perform bimanual exam: place speculum, place

antiseptic on cervix and upper vagina, place cervical tenaculum, and sound the uterus

• In resource-poor areas where full ultrasound evaluation may not be available– Gently sweep uterine sound laterally at fundus– Ensure that IUD is placed at fundus where IUD

arms can open up comfortably and maintain correct placement

Bleeding reduction with LNG-IUS vs NSAID vs tranexamic

acid

LNG-IUS=levonorgestrel-releasing intrauterine system; NSAID=nonsteroidal anti-inflammatory. Reproduced with permission of Milsom I et al. Am J Obstet Gynecol. 1991;164:882.

NSAIDs are therapeutic but not useful as a

prophylactic• NSAIDs reduce bleeding among women with and

without organic pathology of the uterus• They are not as effective as the levonorgestrel-

releasing IUS• A Cochrane Review indicated NSAIDs are effective

for treating pain and bleeding related to IUD use1

• A large study of 2019 first-time IUD users showed that prophylactic ibuprofen had no effect on IUD removal rates due to pain or bleeding2

• NSAIDs are not recommended as a prophylactic, but rather as a therapeutic measure after insertion

1. Grimes DA et al. Cochrane Database Syst Rev. 2006;(4):CD006034. 2. Hubacher D et al. Hum Reprod. 2006;21:1467-1472.

Breast-feeding and combination hormonal contraception

• OB-GYNs have been comfortable recommending nonhormonal or progestin-only contraceptives to breast-feeding mothers

• WHO studies in early 1980s regarding use of combined oral contraceptives1

– Minor effects on quantity and quality of breast milk– No effect on infant growth was seen

• During early months when using the levonorgestrel-releasing IUS, very low serum levels are observed

• No problem offering any of the nonhormonal or progestin-only methods

OB-GYNs=obstetricians and gynecologists; WHO=World Health Organization.1. Truitt ST et al. Cochrane Database Syst Rev. 2003;(2):CD003988.

Case 1: Resolution

• Patient chose levonorgestrel-releasing IUS• Experienced 4 months of erratic spotting• At 9 months post-insertion

– No more days of heavy bleeding– Menstrual cramps decreased substantially

• Patient satisfied with contraceptive decision

Case 2: Birth control for the overweight

woman • A 38-year-old patient referred for sterilization

by primary care physician• Interested in long duration of use• Height: 65 inches (5’5”) tall• Weight: 190 pounds• BMI: 32

BMI=body mass index.

Why sterilization?

• Effective nonsurgical methods exist• Laparoscopic sterilization presents technical

issues in obese women– Thick abdominal walls– Anesthesia risks– Other surgical risks

• Convenience of sterilization is appealing….• But other long-acting and efficacious medical

therapies should be explored

DVT risk and recommended therapy

• Combination hormone contraception is associated with elevated DVT risk

• Age and obesity are also independent risk factors• Recently updated ACOG guidelines1

– Obesity in women >35 years suggests use of progestin-only and/or intrauterine contraceptives

– Discourages use of combination contraceptives• Neither the copper T IUD, the levonorgestrel-

releasing IUS, nor the single-rod progestin-only implant is contraindicated

ACOG=American College of Obstetricians and Gynecologists; DVT=deep venous thrombosis.1. ACOG, Committee on Practice Bulletins-Gynecology. Obstet Gynecol. 2006;107:1453-1472.

Case 2: 10-year follow-up

and resolution • Patient chose the copper T IUD• 10 years later at age 48, should the IUD be

removed? • Studies from the United Nations and Brazil indicate

high efficacy of copper T IUD after the 10-year window1,2

• Spontaneous fertility beyond age 45 is rare and the IUD becomes even more effective

• Keeping IUD for a few more years may be indicated

1. Bahamondes L et al. Contraception. 2005;72:337-341. 2. United Nations (UN) Development Programme, UN Population Fund, WHO and World Bank, Special Programme of Research, Development and Research Training in Human Reproduction. Contraception. 1997;56:341-352.

Case 3: A young woman seeking long-term contraception

• 18-year-old patient• Unintended pregnancy and abortion 16

months ago• Occurred after being prescribed oral

contraceptives• Wants information regarding long-term

contraception

What are the options?

• Oral contraceptives have many benefits but compliance is an issue

• The patch and the ring are also options• Important to remember: a highly effective

method of birth control is important to the patient– Implant is easy to use and remove– Either IUD is also a good option– DMPA should also be considered; however

adolescent women tend to start and stop

Bone density and DMPA

• Highly effective contraception for hundreds of thousands of US teens– May be in part responsible for declines in

pregnancy and abortions among adolescent women in the United States1

• WHO literature review determined there should be no time limitations with use of DMPA for women of any age2

• The FDA may have overreacted

1. Centers for Disease Control and Statistics. MMWR. 1999;48:1073-1080. 2. WHO. July 2005. 2005;80:302-304. Available at: http://www.who.int/wer/2005/wer8035.pdf. Accessed November 14, 2006.

DMPA-IM 150: BMD in adolescent

discontinuers

BMD=bone mineral density; IM=intramuscular. *P<.005 for discontinuers versus nonusers. Scholes D et al. Arch Pediatr Adolesc Med. 2005;159:139-144.

IUDs, monogamy, and STDs

• Hormonal IUDs may not be neutral in terms of risk of infection

• May be positively protective• Study showed a lower risk of IUD removals

due to upper genital tract infection with hormonal IUD vs copper IUD1

• Women at risk of acquiring STDs may want to use hormonal IUD as opposed to copper IUD

STDs= sexually transmitted diseases. 1. Toivonen J et al. Obstet Gynecol. 1991;77:261-264.

Case 3: Resolution

• Patient chose etonogestrel (progestin)-releasing implant

• Experienced some unpredictable episodes of spotting and bleeding

• Understands need for condoms to protect against STDs

• At age 21 she will have to reassess because implant is only effective for 3 years