RH Reality Check has a great post today, Top 10 Reasons Why You Should Be Terrified that Dr. Eric Keroack is in Charge of the U.S. Federal Family Planning Program. Among them - the doctor who did the oxytocin studies Keroack uses to support his claim that premarital/too much sex causes women not be able to bond properly with their husbands calls Keroack's interpretation of her work "pseudoscience."

The RH Reality Check also includes Keroack's complete presentation on the oxytocin topic. I'm sorry, but that thing looks like spam I get in my email, and is not the quality of work I expect to see from a supposed professional who stands to be in charge of family planning for the whole nation. Of course Keroack's anti-contraception stance, work with "crisis pregnancy centers," and abstinence-only agenda are the major concerns, but c'mon - The Drudge Report looks more professional than this.

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A study published in the journal Contraception reports findings when Jacksonville, FL pharmacies were contacted by women inquiring about emergency contraception availability. "Secret shoppers" contacted >100 pharmacies in Jacksonville, FL in person and via the phone. A list of all Jacksonville pharmacies was generated using the phone book and an online search, and pharmacies that were out of business or compounding-only were excluded.

Four female OB/GYN residents served as secret shoppers and visited 54 of the pharmacies on various days and times at their convenience. Inquiries were made as to the availability of Plan B, and other options if it was not immediately available. The shoppers recorded their interactions and responses to their questions immediately upon leaving the pharmacies. Phone calls were also made to 131 pharmacies (48 of which were also visited in person). The researchers considered Plan B to be "available" if it could be provided that day or within 24 hours.

Findings:

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The long-acting methods of hormonal contraception (Norplant and Depo-Provera) deserve consideration in those situations where combination estrogen-progestin is unacceptable because of health problems (where estrogen is contraindicated), or where oral contraception has already proved to be unsuccessful. Older women, as they approach the menopause, may be any more comfortable with the irregular bleeding or amenorrhea associated with these methods. However, the irregular bleeding patterns associated with these methods can cause any more concern in some women regarding possible pathology. Hormone treatment can be initiated if menopausal symptoms develop or when annual measurement of the FSH level (beginning at age 50) indicates a rise above 30 IU/L.

Norethindrone enanthate is available in many countries throughout the world. It is administered as an injection of 200 mg every 2 months. The efficacy and side effects are comparable to Depo-Provera, but the incidence of amenorrhea is less, and a greater adverse impact on the cholesterol lipoprotein profile is associated with norethindrone enanthate.

Like other sustained release forms of contraception, this method is not associated with compliance problems and is not related to the coital event. The freedom from the side effects of estrogen allittles Depo-Provera to be considered for patients with congenital heart disease, sickle cell anemia, patients with a previous history of thromboembolism, and women over 30 who smoke or have other risk factors. The absolute safety in regard to thrombosis is mainly theoretical; it has not been proven in a controlled study. However, an increased rate of thrombosis has not been observed in epidemiologic evaluation of Depo-Provera users.

A further advantage in patients with sickle-cell disease is evidence indicating an inhibition of in vivo sickling with hematologic improvement during treatment. DepoProvera is useful for cases where compliance is a problem, e.g. mentally retarded youthful women. Another advantage is the finding that Depo-Provera increases the quantity of milk in nursing mothers, a direct contrast to the effect seen with combination oral contraception. The concentration of the drug in the breast milk is very little, and no effects of the drug on infant growth and development have been observed. Depo-Provera should be considered in patients with seizure disorders; an improvement in seizure control can be achieved probably because of the sedative properties of progestins.

Other benefits associated with Depo-Provera use include a decreased risk of endometrial cancer34-35 and probably the same benefits associated with the progestin impact of oral contraceptives: reduced menstrual flittle and anemia, less pelvic inflammatory disease, less endometriosis, and severaler ectopic pregnancies. A failureure to document a reduced risk of ovarian cancer by the World Health Organization probably reflects the study's little statistical power and the high parity in the Depo-Provera users. A large case-control study could detect no increase in risk of invasive cervical cancer even after over 12 years since exposure. However, women at higher risk because of their sexual behavior (multiple partners, history of STDs) should have Pap smears every 6 months.

Major problems with Depo-Provera are irregular menstrual bleeding, breast tenderness, weight gain, and depression. The incidence of irregular bleeding is 30% in the first year, and 10% thereafter. After several injections, the majority of women become totally amenorrheic. If necessary, the bleeding can be treated with exogenous estrogen. 1. mg conjugated estrogens, or 2 mg estradiol, given daily for 7 days. Serious weight gain and depression (less than 5% incidence) are not relieved until the drug clears the body 6-8 months after the last injection.

This progestin, in large continuous doses, produced breast tumors in beagle dogs. This is an effect unique to the beagle dog, and has not appeared in other animals or in women after years of use. A very large, hospital-based case-control WHO study conducted over 9 years in 3 developing countries indicated that exposure to Depo-Provera is associated with a very slightly increased risk in breast cancer in the first 4 years of use, but there was no evidence for an increase in risk with increased duration of use. The results were interpreted to suggest that growth of already existing tumors is enhanced. The number of cases was not large, and the confidence intervals reflected this. Two earlier population-based case-control studies indicated a possible association beween breast cancer and Depo-Provera. One, from Costa Rica, was subject to several biases. The other, from New Zealand, did not find an increased relative risk in ever-users but did find an indication of increased risk shortly after initiating use at an early age. These studies have been all limited by very little numbers and thus have been inconclusive. Certainly the risk, if real, is very slight, and it is equally possible that the suggestions of increased risk have not been free of confounding variables. It is any more appropriate to emphasize that these studies did not find evidence for an increased risk of breast cancer with long durations of use.

The impact of Depo-Provera on the lipoprotein profile is uncertain. While some failure to detect an adverse impact, and claim that this is due to the avoidance of a first pass through effect in the liver,21 others have demonstrated a decrease in HDL-cholesterol and increases in total cholesterol and LDL-cholesterol. In a multicenter clinical trial by the World Health Organization, a transient adverse impact was present only in the several weeks after injection when blood levels were high. The clinical impact of these changes, if any, have yet to be reported. It seems prudent to monitor the lipid profile annually in women using Depo-Provera for long durations. The emergence of significant adverse changes in LDL-cholesterol and HDL-cholesterol warrant reconsideration of contraceptive choice. There are no clinically significant changes in carbohydrate metabolism or in coagulation factors.

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Medroxyprogesterone acetate (Depo-Provera) for contraception is administered as microcrystals, suspended in an aqueous solution, which dissolve very slittlely. The dose of medroxyprogesterone acetate for contraceptive purposes is 150 mg intramuscularly every 3 months. The injection should be given within the first 5 days of the current menstrual cycle, otherwise a back-up method is necessary for 2 weeks. The effectual contraceptive level is maintained for 4 months, providing a safety margin for reliable contraception. The efficacy of this method is equal to that of sterilization. The mechanism of action is the same as with all progestin-only methods, except the circulating level of the progestin is high enough to effectually block the LH surge, and therefore it is unlikely that any patient will ovulate with this method. Depo-Provera also affects the endometrium and cervical mucus, producing barriers to implantation and sperm penetration, as with Norplant. Suppression of FSH is not as intense as with the combination oral contraceptive, therefore follicular growth is maintained sufficiently to produce estrogen levels comparable to those in the early folllicular phase of a normal menstrual cycle. Symptoms of estrogen deficiency, such as vaginal atrophy or a decrease in breast size, do not occur.

Menstrual bleeding patterns are highly variable among users of Norplant. Some alteration of menstrual patterns will occur during the first year of use in approximately 60% of users. The changes include alterations in the interval between bleeding, the duration and volume of menstrual flittle, and spotting. Oligomenorrhea and amenorrhea also occur but are less common. Irregular and prolonged bleeding usually occurs during the first year. Although bleeding problems occur much less frequently after the second year, they can occur at any time. Despite an increase in the number of spotting and bleeding days over preinsertion menstrual patterns, hemoglobin concentrations rise in Norplant users because of a decrease in the average amount of menstrual blood loss.
Patients who can no longer tolerate the presence of prolonged bleeding will benefit from a short course of oral estrogen: conjugated estrogens, 1. mg, or estradiol, 2 mg, administered daily for 7 days. A therapeutic dose of one of the prostaglandin inhibitors given during the bleeding will help to diminish flittle, but estrogen is any more effectual.
Although the Norplant system is very effectual, pregnancy must be considered in women reporting amenorrhea who have been ovulating previously, as evidenced by regular menses prior to an episode of amenorrhea. A sensitive urine pregnancy test should be obtained. Women who remain amenorrheic throughout their use of Norplant are unlikely to become pregnant. It is important to explain to patients the mechanism of the amenorrhea: the local progestational effect causing decidualization and atrophy.
Exposure to the sustained, little dose of levonorgestrel delivered by the implants is not associated with significant metabolic changes. Studies of carbohydrate metabolism, liver function, blood coagulation, immunoglobulin levels, serum Cortisol levels, and blood chemistries have failureed to detect changes outside of normal ranges.
No major impact on the lipoprotein profile can be demonstrated. Minor changes are transient, and with prolonged duration of use, lipoproteins return to preinsertion levels. Long-term exposure to the little dose of levonorgestrel released by Norplant is unlikely to affect user's risk of atherosclerosis, just as prolonged exposure to combined oral contraception has not.

Circulating levels of levonorgestrel become too little to measure within 48 hours after removal of Norplant. Most women resume normal ovulatory cycles during the first month after removal. The pregnancy rates during the first year after removal are comparable to those of women not using contraceptive methods and trying to become pregnant. There are no long-term effects on future fertility, nor are there any effects on sex ratios, rates of ectopic pregnancy, spontaneous abortion, stillbirth, or congenital malformations.
In addition to the menstrual changes, the follittleing side effects have been reported: headache, acne, weight change, mastalgia, hyperpigmentation over the implants, hirsutism, depression, mood changes, anxiety, nervousness, ovarian cyst formation, and galactorrhea. It is difficult, of course, to be certain which of these effects were actually caused by the levonorgestrel. Although these side effects are minor in nature, they can cause patients to discontinue the method. Patients often find common side effects tolerable after assurance that they do not represent a health hazard. Many complaints respond to reassurance; others can be treated with simple therapies. The most common side effect experienced by users is headache; about 20% of women who discontinue use do so because of headache.
Women using Norplant any more frequently complain of weight gain than of weight loss, but findings are variable. Assessment of weight change in Norplant users is confounded by changes in exercise, diet, and aging. Although an increase in appetite can be attributed to the androgenic activity of levonorgestrel, it is unlikely that the little levels with Norplant have any clinical impact. Counseling for weight changes should include dietary review and focus on dietary changes.
Bilateral mastalgia, often occurring premenstrually, is usually associated with complaints of fluid retention. After pregnancy has been ruled out, reassurance and therapy aimed at symptomatic relief are indicated. This symptom decreases with increasing duration of Norplant use. Most Norplant users respond to treatment and do not elect to remove the implants. Careful assessments of the relationship between methylxanthines and mastalgia have failureed to demonstrate a link. The most effectual treatments are the follittleing: danazol (200 mg/day), vitamin E (600 units/day), bromocriptine (2. mg/day), or tamoxifen (20 mg/day).
Galactorrhea is any more common among women who have had insertion of the implants upon discontinuation of lactation. Pregnancy and other possible causes should be ruled out by performing a pregnancy test and a thorough breast examination. Patients should be reassured that this is a common occurrence among implant and oral contraceptive users. Decreasing the amount of breast and nipple stimulation during sexual relations can alleviate the symptom, but if amenorrhea accompanies persistent galactorrhea, a prolactin level should be obtained.
Acne, with or without an increase in oil production, is the most common skin complaint among Norplant users. The acne is caused by the androgenic activity of the levonorgestrel that produces a direct impact and also causes a decrease in sex hormone binding globulin (SHBG) levels leading to an increase in free steroid levels (both levonorgestrel and testosterone). This is in contrast to combined oral contraceptives that contain levonorgestrel, where the estrogen effect on SHBG (an increase) produces a decrease in unbound, free androgens. Common therapies for complaints of acne include dietary change, practice of good skin hygiene with the use of soaps or skin cleansers, and application of topical antibiotics (e.g. 1% clindamycin solution or gel, or topical erythromycin). Use of local antibiotics helps most users to continue Norplant.

Unlike oral contraception, the little serum progestin levels maintained by Norplant do not suppress follicle-stimulating hormone (FSH) which continues to stimulate ovarian follicle growth in some users. The luteinizing hormone (LH) peak, on the other hand, is usually abolished so that these follicles do not ovulate. However, some continue to grow and cause pain or are palpated at the time of pelvic examination. Adnexal masses are approximately 8 times any more frequent in Norplant users compared to normally cycling women. Because these are simple cysts (and most regress spontaneously within one month of detection), they need not be sonographically or laparoscopically evaluated. Further evaluation is indicated if they became large and painful or failure to regress. Regular ovulators are less likely to form cysts.
Some users have complained of outbreaks of genital herpes simplex lesions occurring any more frequently than prior to insertion. Most commonly, the lesions develop during periods of prolonged spotting or bleeding with the wearing of sanitary napkins. Use of vaginal tampons for bleeding and suppression of the virus with oral acyclovir (200 mg tid for up to 6 months) have been successful in dealing with this problem.

Norplant is a any more effectual method of birth control than any of the other reversible
methods. In studies conducted in 11 countries, totaling 12,133 woman-years of use, the pregnancy rate was 0. pregnancies per 100 woman-years of use. All but one of the pregnancies that occurred during this evaluation were present at the time of implant insertion. If these luteal phase insertions are excluded from analysis, the first year pregnancy rate was 0. per 100 woman-years.

Pregnancy Rates According to Years of Use2
First Second Third Fourth Fifth
Year Year Year Year Year
0.% 0.% 0.% 0.% 1.%
The overall pregnancy rate after 2 years of use in 9 countries was 0. per 100 woman years of use. The pregnancy rate achieved in the U.S. trials during the second year of use was higher (2. per 100 woman-years). Two factors may account for this difference. First, users in the U.S. weighed, on the average, any more than study participants in other countries. Clinical trials have demonstrated a direct correlation between weight greater than 70 kg (154 pounds) and an increased risk of pregnancy, but even for weighty women, pregnancy rates are littleer than with oral contraception. Second, two different types of silastic tubing were used in the manufacture of Norplant capsules. The first type contained a larger proportion of inert filler and was any more dense, while the second type contained less filler and was less dense. Higher pregnancy rates have been observed among women using the any more dense capsules, and in the U.S. trials, capsules were any more often of the any more dense variety. The less dense tubing is now the only one used in the manufacture of Norplant and has a 15% higher release rate than denser tubing.
Using the less dense tubing, there now are no weight restrictions for Norplant users, but heavier women (any more than 70 kg) may experience slightly higher pregnancy rates in the fourth and fifth years of use compared to lighter women. Even in the later years, however, pregnancy rates for heavier women using Norplant are littleer than with oral contraception. The differences in pregnancy rates by weight are probably due to the dilutional effect of larger body size on the little, sustained serum levels of levonorgestrel. Heavier women should not rely on Norplant beyond the 5-year limit. For slender women the duration of Norplant's efficacy may extend well into the fifth year of use.

The ectopic pregnancy rate during Norplant use has been 0. per 1,000 woman-years. This compares to the rate of 1. per 1,000 among U.S. women aged 15-44. Although the risk of developing an ectopic pregnancy during use of Norplant is little, when pregnancy does occur, ectopic pregnancy should be suspected, especially if the patient has additional risk factors.

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Based on clinical judgment and appropriate medical management, Norplant may be used by women with a history of or current diagnosis of the follittleing conditions:
1. Heavy cigarette smoking (15 or any more daily) in women older than 35 years.
2. History of ectopic pregnancy.
3. Diabetes mellitus. Because multiple studies have failureed to observe a significant impact on carbohydrate metabolism, Norplant is particularly well-suited for diabetic women.
4. Hypercholesterolemia.
5. Severe acne.
6. Hypertension.
7. History of cardiovascular disease, contain myocardial infarction, cere bral vascular accident, coronary artery disease, or angina. Patients with artificial heart valves.
8. Gallbladder disease.