# Presentation: 513337

## Adolescent Contraception: Pills, Shots, Patches and Rings

**John Kulig, MD, MPH**
**Laurie Hornberger, MD, MPH**
**Job Corps Regional Medical Consultants**

## Slide 2

## Sexual risk behavior

- ever had sexual intercourse		male		female
- 				grade 9	           41%		29%
- 				grade 10		42%		39%
- 				grade 11		54%		50%
- 				grade 12		61%		60%
- _>_4 lifetime sexual partners		male		female
- 				grade 9		14%		  6%
- 				grade 12		24%		20%
- 			Source: CDC 2001 Youth Risk Behavior Survey

## Sexual risk behavior

- initiation of sexual intercourse before age 13
- 		male students	     	9%
- 		female students	     	4%
- 		white students	     	5%
- 		black students	        16%
- 		Hispanic students    	8%
- 		all students		     	7%
- 		Source: CDC 2001 Youth Risk Behavior Survey

## Sexual risk behavior

- condom use during last sexual intercourse
- 			white students	   	57%
- 			black students	   	67%
- 			Hispanic students		54%
- alcohol or drug use at last sexual intercourse
- 			male students	   	31%
- 			female students		21%
- 			white students	   	28%
- 			black students	   	18%
- 			Hispanic students		24%
- 		Source: CDC 2001 Youth Risk Behavior Survey

## Slide 6

## Adolescent Pregnancy

***  ******“******Have been pregnant or gotten someone pregnant.”***
- 			male 		  4%
- 			female		  5%
- 			white		  3%
- 			black		11%
- 			Hispanic		  6%
- 		    Source: CDC 2001 Youth Risk Behavior Survey

## Slide 8

## Slide 9

## Oral Contraceptive Pills

## New progestins

- 1st generation:
- 	norethindrone
- 2nd generation:
- 	norgestrel
- 	levonorgestrel

- 3rd generation:
- 	desogestrel
- 	norgestimate
- new:
- 	drospirenone

## Noncontraceptive Benefits of OCs

**Noncontraceptive Benefits of OCs**

- decrease menstrual flow (lighter, shorter periods)
- decrease menstrual cramps (no ovulation)
- improve anemia (lighter, shorter periods)
- improve acne (estrogen effect)
- protect against ovarian and endometrial cancer
- decrease benign breast disease
- decrease ovarian cyst formation
- prevent ectopic pregnancy
- protect against some causes of PID
- protect against osteoporosis

## Oral Contraceptives and Risk of Breast Cancer

- study of 4575 women with breast cancer and 4682 controls - age 35 to 64 years at interview
- relative risk 1.0 [0.8-1.3] for current OC users
- relative risk 0.9 [0.8-1.0] for previous OC users
- similar results in white and black women
- relative risk did not increase with longer use or with higher estrogen dose
- no increased risk associated with initiation of OC use in adolescence
- 					      NEJM 2002;346:2025-2032

## Drug Interactions with OCs

-  most anticonvulsants
- 	 (except valproate)
-  rifampin
-  griseofulvin
-  St. John’s Wort

## Seasonale®

- extended regimen combined oral contraceptive pills with ethinyl estradiol and levonorgestrel
- 91 day cycles - 84 days on - 7 days off
- 4 menstrual cycles per year - one each season
- clinical trials underway
- FDA approval anticipated in 2004

## Emergency Contraception

## What is the best method of emergency contraception (EC) for use by adolescents?

- Options:
- Yuzpe method (1982)
- combination oral contraceptive pills
- progestin-only pills
- dedicated emergency contraceptive pill products: Preven**®** and Plan B**®**
- mifepristone (RU486)
- insertion of intrauterine device

## Ovral ®

**Ovral ****®**

**Lo-Ovral ****®**

## Slide 19

## Ovrette ®

**Ovrette ****®**

## Slide 21

## Slide 22

## Mifepristone (RU486)

**Mifepristone (RU486)**

## Slide 24

## How does EC work?

- mechanism of action of levonorgestrel _+_ ethinyl estradiol may depend upon timing during the menstrual cycle
- principal mechanism is prevention of ovulation
- may thicken cervical mucus
- may interfere with transport of sperm, ova or zygote
- may inhibit implantation

## How does EC work?

- onset of pregnancy is medically defined as implantation of a fertilized ovum in the wall of the uterus (ACOG)
- levonorgestrel _+_ ethinyl estradiol is _not _effective once implantation occurs
- levonorgestrel _+_ ethinyl estradiol does _not_ induce abortion

## How effective is EC?

- Pregnancy risk:
- 33% per cycle if sexually active qod
- 15% per cycle if sexually active once a week
- condom failure reported by 4%-7% of couples during a three-month interval
- EC use could prevent 2 million unintended births and 1 million induced abortions each year in the US

## How effective is EC?

- Yutzpe regimen data:
- EC efficacy 74% by meta analysis of ten studies
- 0.5%-1.5% observed vs 4.7%-5.5% expected pregnancy rate
- no absolute contraindications except pregnancy
- no demonstrable teratogenicity

## How effective is EC?

- Importance of timing: combined pill data
- 77% effective if taken within 24 hours of unprotected intercourse
- efficacy declines to 36% if treatment is delayed 25-48 hours
- efficacy declines to 31% if treatment is delayed beyond 48 hours

## How effective is EC?

- Importance of timing: Plan B**®** data
- 95% effective if taken within 24 hours of unprotected intercourse – reduces crude pregnancy rate from 8% to 0.4%
- efficacy declines to 85% if treatment is delayed 25-48 hours
- efficacy declines to 58%-61% if treatment is delayed beyond 48 hours

## Are there medical contraindications to EC use?

- only absolute contraindication is pregnancy (because EC will not work)
- no evidence of harm to a developing fetus
- no concern about estrogen-related contraindications with progestin-only EC
- potential drug interactions with certain anticonvulsants, rifampin and griseofulvin may reduce efficacy

## Is pregnancy testing necessary before using EC?

- EC is ineffective if implantation has occurred
- no evidence of harm to developing fetus if EC is taken inadvertently
- routine pregnancy testing is not recommended
- consider pregnancy testing _prior_ to EC use if menses delayed
- consider pregnancy testing _after_ EC use if menses does not occur within 3 weeks

## Should an anti-emetic be prescribed with EC?

- Nausea:
- 	Yuzpe regimen		50.5%
- 	 Plan B**®** 			23.1%
- Vomiting:
- 	Yuzpe regimen		18.8%
- 	 Plan B**®** 			    5.6%
- Data from a multi-center randomized clinical
- trial of 1,998 women.

## Should EC be prescribed in advance of need?

- women receiving EC in advance are two to three times more likely to use them, but not to use them repeatedly (US/Scotland)
- 80% of women who received EC in advance began treatment within 24 hours of intercourse vs 40% of women who needed to fill an EC prescription
- no more likely to engage in sexual activity
- no more likely to use their regular contraceptive less consistently

## Should EC be prescribed in advance of need?

- fewer than one third of female adolescents have heard of EC (1998 data)
- 17% of young women report no use of contraception at most recent intercourse
- 20% of women report forced sexual intercourse and 72% were under age 20 at the time of the experience (NCHS)
- lack of clinician availability on weekends may disproportionately affect adolescents

## Should EC be made available without a clinician’s prescription?

- Citizen’s Petition filed with the FDA in February 2001 – 70 organizations
- currently available over-the-counter in 13 industrialized nations
- currently available from pharmacists in the states of California and Washington
- 					Ref: NEJM 2002;347:846-849

## Should EC be made available without a clinician’s prescription?

- Arguments _in favor_ of OTC availability:
- improved public health
- delays in treatment lead to more unintended pregnancies
- easier access to EC 24 hours a day
- safe for self-medication
- same dose for all women
- same medications safely used for contraception for decades
- serious adverse effects do not occur, even with inappropriate use

## Should EC be made available without a clinician’s prescription?

- Arguments _opposed_ to OTC availability:
- no clinician contact to discuss potential side effects
- missed opportunity for contraceptive counseling
- may make refusal of sexual intercourse more difficult
- EC is a euphemism for induced early abortion
- EC might unintentionally be used in pregnancy
- EC use might undermine use of non-emergency contraception, including barrier methods

## Does knowledge of EC alter adolescent sexual behavior?

- study of 916 male and 852 female students age 14-15 in 12 schools in UK
- single lesson on emergency contraception
- improved knowledge persisted six months later in comparison with controls
- no difference in sexual activity, intent to use EC or use of EC
- 					Ref: BMJ 2002:324:1179-1183

## Emergency Contraception Resources

- EC hotline	1.888.NOT.2.LATE
- EC website	_[http://not-2-late.com](http://not-2-late.com/)_
- Clinician’s guide to providing EC	_[http://www.piwh.org/publications.html](http://www.piwh.org/publications.html)_
- Consortium for Emergency Contraception _[http://](http://www.cecinfo.org/)__[www.cecinfo.org](http://www.cecinfo.org/)__[/](http://www.cecinfo.org/)_

## Progestin-only Injectable Contraception

## Slide 42

## Depo Provera

-  depot medroxyprogesterone acetate
-     150 mg IM once every 12 weeks
-  irregular bleeding => amenorrhea
-     within 2 years  (70%)
-  concerns:
- 			weight gain
- 			osteoporosis risk

## Combined Injectable Contraception

## Combined injectable contraceptives

**Combined injectable contraceptives**

- Lunelle****:
- 25 mg depot-medroxyprogesterone acetate and 5 mg estradiol cypionate injected (IM) once a month
- 0.5 mL IM q 30 days _+_ 3 days
- FDA approved in October 2000
- prefilled syringes withdrawn from the market in October 2002 - potency concerns

## Slide 46

## Lunelle : Mechanisms  of Action

**Lunelle******** : Mechanisms  of Action**

**Suppress ovulation**

**Change endometrium making implantation less likely**

** **

** **

**Thicken cervical mucus preventing sperm penetration**** **

**Reduce sperm transport in upper genital tract (fallopian tubes)**

## Lunelle : Contraceptive Benefits

**Lunelle******** : Contraceptive Benefits**

- highly effective (0.1-0.4 pregnancies per 100 women during the first year of use)
- effective immediately
- does not interfere with intercourse
- few side effects
- can be provided by trained nonmedical staff
- no supplies needed by the patient

## Lunelle : When to Start

**Lunelle******** : When to Start**

- anytime you can be reasonably sure the patient is not pregnant
- days 1 to 7 of the menstrual cycle
- postpartum:
- after 6 months if breastfeeding
- after 3 - 6 weeks if not breastfeeding
- postabortion (immediately or within 7 days)

## ContraceptivePatch

## Ortho Evra

- seven day contraceptive patch
- 13/4 inch three layer adhesive patch
- contains both estrogen and progestin
- applied to the buttocks, lower abdomen or upper body
- newly applied weekly for three weeks, then one week off for menses
- less effective in women over 198 pounds
- approved by the FDA in November 2001

## Slide 52

## Ortho Evra

- Side effects leading to discontinuation:
- nausea (2%)
- moodiness (1.5%)
- headache (1.1%)
- breast discomfort (1%)
- irritation at application site (1.9%)
- Inadvertent detachment uncommon (1.9%), even with exercise, humid climates, saunas, hot tubs

## ContraceptiveVaginal Ring

## NuvaRing

- contraceptive vaginal ring - 2 inch diameter
- worn for 21 days => removed for 7 days to allow menses => replaced with new ring
- releases 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily
- one size only - does not require fitting
- cannot be inserted incorrectly
- no increase in vaginal infections/discharge
- 3 hour window after inadvertent removal

## Slide 56

## ContraceptiveImplant

## Slide 58

## Implanon

- progestin-only contraceptive implant
- single flexible 4 cm rod inserted under the skin of the upper arm
- contains 68 mg etonogestrel - releases
- 	40 mcg daily - 3 year efficacy
- no pregnancies in 73,000 monthly cycles
- irregular menstrual bleeding common
- clinician visit for insertion and removal

## Slide 60

## Intrauterine Contraceptive System

## Mirena

- levonorgestrel-releasing intrauterine system - 20 mcg daily - 5 year efficacy
- highest risk of PID within 20 days of insertion
- irregular menstrual bleeding common in first 3-6 months
- clinician visit for insertion and removal

## Slide 63

## Condom Use and Hormonal Contraception

- Consistent condom use
- 			OCs			21%
- 			DMPA		18%
- 			Norplant		  9%
- Condom use at last intercourse
- 		hormonal contraception		52%
- 		no hormonal contraception	69%

## FemCap

- silicone rubber cervical cap - less irritating than latex
- used with microbicide/spermicide
- worn for up to 48 hours
- 3 sizes:
- small (22 mm) - never pregnant
- medium (26 mm) - pregnant, no vaginal delivery
- large (30 mm) - vaginal delivery at term
- can reuse for two years
- FDA approved in March 2003

## Slide 66

## “The Contraceptive Report”

- Quarterly update on advances in contraceptive technology
- Available online at:   www.contraceptiononline.org/contrareport/issue.cfm
- Subscribe for free at:
-    www.emron.com/TCR

## Sexually Transmitted Disease Guidelines

**Centers for Disease Control and Prevention**
**May 2002**

## Chlamydia

- All sexually active adolescent and young adult women should be screened annually, regardless of the presence or absence of symptoms.
- All women with Chlamydia infections should be rescreened 3-4 months after treatment is completed.

## Gonorrhea

- Resistance to fluoroquinolone antibiotics (ciprofloxacin,ofloxacin,levofloxacin) has been found on the West Coast.  It is unknown how extensive this resistance will become or how quickly it may spread.
- Cefixime and ceftriaxone are now considered first line drugs to treat GC on the West Coast, but cefixime is no longer manufactured in the US.

## Gay and bisexual males

- Expanded risk assessment - annual screening:
- Chlamydia (anal, urethral)
- gonorrhea (anal, urethral, pharyngeal)
- HIV
- syphilis
- Routine vaccination for hepatitis A and hepatitis B

## Use of Nonoxynol-9

- Frequent use of the spermicide nonoxynol-9 has been shown to cause genital (vaginal, rectal) lesions that can increase the risk of HIV transmission
- Condoms lubricated with nonoxynol-9 are no longer recommended
- Previously purchased condoms with N-9 can be used up until their expiration date

## 2002 CDC STD Guidelines

- Two copies mailed to each center by Humanitas in February 2003 - one for center physician - one for Wellness Center reference
- Order by phone: 1-888-232-3228
- Order online: www.cdc.gov/std => www.cdc.gov/std/treatment/default.htm

## Slide 74