Lecture 9 Over the Counter Reproductive Health Care Peterson

SPERMICIDES, FILMS AND CONTRACEPTIVE SPONGE:

SPERMICIDE:

• Chemical agent that kills or immobilizes sperm

• Spermicidal agent incorporated into vehicle allowing for dispersal and

retention of spermicide in vagina where it acts as both a physical and

chemical barrier to sperm motility

SPERMICIDAL AGENTS:

• Spermicidal active ingredients commonly used:

o Noxynol-9 (N-9)

o Lactic acid

o Menfegol

• Formulated in a safe, inert vehicle consisting of ≥ 1 suitable thickening

agents, humectants, buffering agents, preservatives & water

N-9 SPERMICIDES:

• MOA: acts as a surfactant which destroys sperm cell membrane by

altering lipid layer so that spermatozoon becomes permeable and swells,

with breakage of plasma and acrosomal membranes

o Minimum effective dose: 100 mg N-9

o Failure rate : 18 – 28%

• May also increase genital irritation or cause epithelial disruption leading

to easier transmission of HIV and other STIs

• Associated with ↑ risk of E. coli UTIs due to alteration of vaginal flora

CONTRACEPTIVE FILM – VCF:

• MOA: physical and chemical barrier to sperm

o N-9 in film base that dissolves at body temp to form gel barrier

o Failure rate: 6 – 28%

• Effective after 15 mins and up to 3 hours after insertion

o Additional film required for each act of intercourse

• Available on pharmacy shelves and online

CONTRACEPTIVE SPONGE – TODAY:

• Small, one-size-fits-all, disposable, polyurethane foam device intended

to fit over the cervix impregnated with a spermicidal agent

o MOA: contraceptive action primarily provided by the

spermicide impregnated in the sponge, augmented by its ability

to absorb and trap sperm

o Failure rate: 9-12% in nulliparous; 20-24% in parous women

• Effective for multiple acts of intercourse over 24-hour period

o May be forgotten and left in place = toxic shock potential

• Available on pharmacy shelves & internet

LACTIC ACID SPERMICIDES – CONTRAGEL, CAYA GEL:

• MOA: some evidence that lactic acid reduces pH of vagina, reducing

sperm motility

o Marketed as a green, natural, alternative to N-9 spermicides

▪ Less irritating than N-9

o Failure rates: ??

• Compatible with latex, polyurethane and silicon devices

SPERMICIDE INDICATIONS:

• Suitable contraceptive for women unable/unwilling to use hormonal or

IUD methods

• Dual protection with other methods of contraception as important

contributor to efficacy of contraceptive devices (sponge, male condom,

diaphragm and cervical cap)

SPERMICIDE CONTRAINDICATIONS:

Absolute • High risk for HIV

Relative • Allergy to spermicidal agent

• History of TSS

• HIV positive or AIDs diagnosis

• Use of antiretroviral therapy

Not recommended for:

• Women uncomfortable touching their genitals

• Women with personal/medical need for highly effective contraception

• N-9: women with chronic UTIs

• Sponge/film: women with abnormal vaginal anatomy, physical disabilities or neurological impairment which limits ability to insert or remove the device

• Sponge: within 6 weeks of delivery, miscarriage or abortion

MALE CONDOMS:

MALE CONDOMS:

MOA: • Physical barrier o Prevents passage of sperm o Decreases contact with semen, bodily fluids & genital lesions

INDICATIONS: • Prevention of pregnancy – ideally dual protection

• Prevention of transmission of STIs and cervical dysplasia

EFFECTIVENESS: • Contraceptive failure rate: 3 – 14%

• STI transmission failure rate: variable

AVAILABILITY:

• Non-prescription – various brands

• Various shapes, sizes, textures, colors, lubrications

• Various materials including: latex, polyisoprene,

polyurethane, tactylon, lambskin

• Optimal fitting requires trying variety of condoms

o Online condom sizing charts available

CONDOM TYPES:

LATEX: • Manufactured from natural latex rubber; 0.3 – 0.8 mm thickness

• Offered in variety of colors, shapes, sizes, widths, lengths, textures and lubrication

• CANNOT be used by those sensitive/allergy to latex OR with oil-based lubricants

• Offer BEST protection against pregnancy

POLYISOPRENE: • Manufactured from latex that has been put through a process to remove latex allergens o Fewer medical events than latex condoms o Transmits more heat, allowing more sensitivity

• Similar to latex in terms of preventing pregnancy & transmission of STIs (no published data)

• Cannot be used with oil-based lubricants

POLYURETHANE: • May offer better physical properties than latex condoms: o Similar to polyisoprene in terms of warm feel; can be formulated to feel thinner than actually are; less constricting fit o More resistant to deterioration; compatible with oil-based lubricants BUT higher slippage and breakage rates than latex o Can be used by those sensitive or allergic to latex o More expensive

LAMBSKIN: • Made from lamb’s intestine; cannot be used by those with lanolin sensitivity

• Not recommended because of lack of protection against STIs transmitted by viral organisms o Lab tests have shown passage of HIV, hepatitis B & HSV through small pores on surface of lambskin condoms

Lecture 9 Over the Counter Reproductive Health Care Peterson

MALE CONDOMS (CONTINUED):

COMMON CAUSES OF CONDOM FAILURE:

1. Slippage rates: between 0.90 – 1.28%

• Associated with use of lubricants:

o ↑ rates in vaginal intercourse

o ↓ anal in vaginal intercourse

2. Breakage rates: between 2.8 – 3.42%

• Rough handling

• Lengthy/intense intercourse

• Use of oil-based lubricants

• Incorrect storage and usage after expiry date

• Failure to leave space or remove air at tip

• Concurrent use of alcohol and/or drugs

3. Late application or early removal

4. Inconsistent use; non-use; re-use

5. Applying condom inside out

ADVANTAGES VS. DISADVANTAGES:

Advantages Disadvantages

• Protection against STIs

• ↓ likelihood of infertility or cervical neoplasia by ↓ risk of STIs

• Up to 80% reduction in HIV transmission when used correctly or consistently

• Relatively inexpensive

• Widely available and accessible

• More/less stimulation – premature ejaculation

• No prescription required

• Convenient/portable/discreet

• Low incidence of side effects

• Enhances other contraceptive methods

• May break or slip

• Requires motivation & responsibility to use

• Interrupts intercourse – must be put on the penis before any genital contact

• Loss of spontaneity

• Potential latex allergy and lanolin sensitivity to lambskin condoms

• Decreased sensation

• May interfere with maintenance of erection

• Awareness of presence

• May have unpleasant taste

• Less protection against HSV or HPV

• Must withdraw promptly after ejaculation

• Can be used only once

• N-9 lubricated condoms increase risk of E. coli and UTIs + transmission of HIV and STIs

FEMALE CONDOMS:

FEMALE CONDOMS:

MOA: • Physical barrier o A soft, loose, fitting sheath which acts as an intravaginal

barrier to semen and bodily fluids

INDICATIONS: • Prevention of pregnancy

• Prevention of transmission of STIs

EFFECTIVENESS: • Contraceptive failure rate: 5 – 21%

• STI transmission failure rate: variable (as much as male condom)

TYPES OF FEMALE CONDOMS:

• FC1 – original female condom (polyurethane)

• FC2 – 2nd generation female condom (nitrile rubber)

o More cost-effective

o Efficient manufacturing process

o No seam in the condom

o Softer material that is quitter during use

o Thicker and less tear resistant

REALITY FEMALE CONDOM:

• Soft, thin sheath with 2 flexible rings; one unattached

ring at one end (closed) and slightly larger, attached

ring at opposite end (open) of condom

o Inner ring is inserted into vagina & placed over

cervix to anchor it in place in vagina

o Outer ring rests outside vagina & keeps condom

from being pushed inside vagina during use

COMMON CAUSES OF CONDOM FAILURE:

1. Breakage rates: 0.5 – 2.1%

2. Slippage rates: 5.1 – 6.13%

3. Invagination (outer ring gets pushed in)

4. Misdirection (penis misses condom)

ADVANTAGES VS. DISADVANTAGES:

Advantages Disadvantages

• Protects against pregnancy about as well as a male condom

• Decreased risk of STIs

• Less likely to cause allergic reaction vs. male latex condom

• Less likely to break or tear than latex male condom

• Does not deteriorate on exposure to oil-based lubricants

• No prescription required

• Shared responsibility with partners

• A woman can place it autonomously and has full control of effectiveness

• Adjusts well to anatomy of vagina

• Less disruptive than male condom – can be inserted ahead of time (up t o 8 hours prior)

• Withstands storage better than latex – shelf-life up to 5 years

• Should be used only once

• Costs $3-5 per condom

• Availability issues

• Insertion and removal difficulties – need to practice insertion and use device several times before confident with use

• Higher slippage rates than male condom

• Outer ring is somewhat cumbersome

• Aesthetically unacceptable to some

• Pain during intercourse – inner ring may cause some discomfort during coitus

• Does not provide complete protection against all STIs

• Higher failure rate than male condom

• Polyurethane product makes crackling and popping noise during intercourse (noise with FC1 condom)

DIAPHRAGM AND CAPS:

DIAPHRAGM: A soft shallow silicone dome-shaped contraceptive device with either an encased flexible steel or nylon rim around its edge

Milex Wide-Seal Diaphragm SILCS Caya Diaphragm

• Flexible steel rim (arching & omniflex rim styles) + silicone dome o Wide rim provides increased suction and seal

• Available in eight sizes (60-95 mm)

• Pelvic exam and fitting required by trained clinician

• Yearly replacement recommended

• Nylon rim + silicone dome

• Available in one size (67 mm)

• No fitting necessary – fits most women (sized between 65-80 mm for traditional diaphragm)

• Replace every 2 years

CERVICAL CAP: • FemCap available online; 22, 26, 30 mm sizes (sizing based on obstetrical history)

• Replace yearly

MOA: Contraceptive devices designed to be used in conjunction with spermicidal gel providing both physical & chemical barrier to spermatozoa

INDICATIONS: • Prevention of pregnancy

• Well suited for women who do not wish to use hormonal contraception for personal or medical reasons

• Caps often used by women who cannot use a diaphragm

EFFECTIVENESS: • Diaphragm failure rate: 6-12% (N-9); 12 – 23.6% (N9 or acid buffering)

• Cap failure rate: nulliparous 14%, parous 29%

Lecture 9 Over the Counter Reproductive Health Care Peterson

DIAPHRAGM AND CAPS (CONTINUED):

CONTRAINDICATIONS AND CAUTIONS:

DIAPHRAGMS & CAPS:

• Known hypersensitivity to silicon

• History of toxic shock syndrome (TSS)

• Use within 6 weeks of childbirth

DIAPHRAGMS • Uterine prolapse, rectocele or cystocele

• Acute or chronic – recurrent UTIs

• Refit required after childbirth, 2nd trimester abortion, genital surgery or weight gain/loss > 10 lbs

CAYA DIAPHRAGM

• Women previously fit with diaphragm sizes > 60 mm or > 85 mm

DIAPHRAGM ADVANTAGES VS. DISADVANTAGES:

Advantages Disadvantages

• Ability to insert device just before intercourse or up to 30-60 min prior may allow more spontaneity

• Rarely causes discomfort and reduced pleasure during intercourse

• Convenient for women only requiring contraceptive on an occasional basis

• Must be used with spermicide (most effective)

• Refitting is required after pregnancy, abortion, miscarriage, pelvic surgery, or significant weight loss/gain (10-20 lbs)

• Proper insertion requires practice

• Some require fitting by trained clinician

• Showering after intercourse is safe but bathing is not – may wash away spermicide

• If multiple acts of intercourse occur during a 6-hour period, must re-apply spermicide before each act

• May increase risk of persistent UTI – pressure on bladder can change size or rim type

• May increase risk of Toxic Shock Syndrome (TSS)

• Odor if left in place longer than recommended

• Potential allergic rxn to material

CAPS DISADVANTAGES VS. DISADVANTAGES:

Advantages Disadvantages

• Smaller and generally more comfortable than a diaphragm

• Requires less spermicide than a diaphragm

• Inexpensive and re-usable

• May be left in place for up to 48 hours

• Does not protect against transmission of STIs or HIV

• More difficult to insert than diaphragm

• Bacteria may grow inside the cap – TSS

• Unpleasant odor if used for longer than 48 hours

• Higher failure rate than diaphragm

• Less effective in nulliparous women

LUBRICANTS:

PERSONAL LUBRICANTS:

• Used during intercourse to:

o Reduce friction with genital/anal tissue

o Increase comfort and pleasure during sexual intercourse

o Relieves vaginal dryness associated with:

▪ Certain medications

▪ Low estrogen levels during peri-menopause, menopause, post-partum period, breastfeeding, and immediately following menses

▪ Sexual dysfunction

• Types of lubricants: water, silicon, oil

FORMULATION: WATER-BASED

• Most are made up of one or more of the following ingredients:

o Hydrophilic polymers

o Humectants (glycols)

o Viscosity modifiers (cellulose)

o Moisturizers (cellulose, glycols)

o Preservatives (parabens, sorbates, phenoxyethanol, benzoic acid)

o pH balancing agent

• Many water based lubricants are hyperosmolar causing fluid loss from

vaginal and rectal cells resulting in fragility and damage to the epithelium,

potentially increasing the risk of transmission of STIs and HIV

o Glycerin, glycerol and glycol containing products implicated

FORMULATION: SILICONE

• Alternative to water-based lubricants

• Chemically inert and water resistant

• More expensive than water-based lubricants

• Common ingredients: cyclomethicone, dimethicone, silicone,

dimethicone copolyol – all silicone liquids that combine together to

create inert silicone lubricant

FORMULATION: OIL-BASED – NOT RECOMMENDED

• Petroleum-based and other oils destroy latex upon contact (some

condoms, historically some diaphragms, and protective coatings

around some IUDs)

• Oils can be irritating, difficult to remove and can coat inside of

vagina/rectum providing a breeding ground for pathogenic bacteria

ADVANTAGES VS. DISADVANTAGES:

Lubricant Advantages Disadvantages

Water-based • Relatively low cost

• Easily washes away with water

• Most widely available on market

• Tendency to dry out during use, requiring constant reapplication

• Incompatible with sexual activity occurring in water

• Potential for hyperosmolar products to disrupt vaginal/rectal epithelium and increase risk of STI transmission

Silicone-based • Ideal for using in or under water

• Constant reapplication not necessary

• Available in a variety of consistencies

• May leave an oily residue on skin/fabric

• More expensive

• Not all silicon products compatible with latex - * check label

Lecture 9 Over the Counter Reproductive Health Care Peterson

FERTILITY AWARENESS METHODS (FAM) OF CONTRACEPTION:

• Rely on an understanding of the physiology of the menstrual cycle and the timing of ovulation to schedule intercourse in order to prevent a pregnancy

• Can be also used to maximize the potential for conception

• Several FAM including Standard Days, Calendar Days, Sympto-thermal, Cervical Mucus, Two Day and Basal Body Temperature methods

BASAL BODY TEMPERATURE METHOD:

• Measure temperature daily to detect an increase of 0.2 – 0.6o C over 3 days (stays elevated till beginning of next cycle)

o When ovulation occurs, progesterone is released which causes this rise in temperature

• Use a basal thermometer which detects smaller fluctuations than a regular thermometer

• Helps predict window of next cycle (won’t help in the same cycle)