More than 100 million women use oral contraceptives (birth control pills) globally. These pills come with its conveniences and benefits in providing an effective form of birth control, but they also come with their side effects (headache, irregular bleeding, bloating). Some side effects however, can be dangerous such as venous and arterial thrombophlebitis (blood clots), heart attack and stroke. With so many birth control pills on the market, including generics, it is important to look at which pills are safest to avoid these concerning side effects.

In an observational study of 5 million French women (ages 15-49), researchers examined women taking birth control pills with 30-40 ug ethinyl estradiol (EE) compared to those taking a 20 ug EE pill between 2010-2012. Those containing the lowest amount of estrogen (20-ug EE plus levonorgestrel) had the lowest risk for pulmonary embolism, stroke and heart attack. Common names of these pills include Alesse, Lutera, Lessina, Levlite and Sronyx. Those taking the higher 30-40 ug EE plus Desogestrel pill ( Desogen, Ortho-cept) had the highest risk for blood clots of the lungs (pulmonary embolism).

So if choosing a birth control pill, the lower dose estrogen pill is a safer start. Cigarette smoking negates that risk reduction so please don’t smoke.

Also, we have to remember that pregnancy is associated with a much higher risk for venous thromboembolism then any available estrogen-progestin contraceptive. If remembering to take a pill every day is difficult, then consider a long-acting reversible contraceptive, like the IUD or a progestin implant.

Reference: Weill A et al. Low dose oestrogen combined oral contraception and risk of pulmonary embolism, stroke, and myocardial infarction in five million French women: Cohort study. BMJ 2016 may 10;353:i2002.

Sexual dysfunction is common in women of all ages, but for women in menopause (both natural and surgically induced) the symptoms are elevated due to declining levels of estrogen and testosterone. Although estrogen therapy improves vaginal dryness and pain, some women prefer to use a non-estrogen option. 

Sex steroids are vital for healthy tissue integrity of the labia, vagina, lower urinary tract and supporting pelvic structures. These tissues are rich in estrogen and androgen receptors. These hormones enhance blood flow to the genital tract which is necessary for general arousal and lubrication. 

The fall in estrogen at menopause and the decline in androgens (mainly testosterone) as we age results in vulvovaginal atrophy (VVA) and an increase in vaginal PH. Theses changes allow the environment to be vulnerable for vaginal infections. Symptoms include vaginal dryness, irritation, itching, infection and pain with intercourse. This leads to diminished sexual desire, arousal difficulties, reduced physical and emotional satisfaction, and relationship issues. 

Vaginal estrogen therapy can thicken and revascularize the vaginal tissue, lower the PH and normalize vaginal flora. Although data show that vaginal estrogen acts locally,  some studies have shown blood estradiol levels increase with vaginal estrogen application. Therefore, researchers have looked for alternatives for women whom cannot or should not risk raising their level of estrogen such as women who have had estrogen receptor positive breast cancer. The adrenal hormone dehydro-epiandrosterone (DHEA) is an important precursor for the biosynthesis of estrone and testosterone. 

A randomized controlled trial of the daily application of three different doses of vaginal DHEA ovules (3.25 mg, 6.5 mg, or 13 mg) was studied over 12 weeks in 218 postmenopausal women who met the entry criteria of dyspareunia (pain with intercourse). This one study resulted in a number of publications to support the effectiveness of this treatment for VVA. In these publications the investigators reported an improvement in the vaginal cells and a reduction in PH. At 12 weeks,  the total Menopause Quality of Life Questionnaire (assessing sexual desire, vaginal dryness, intimacy) scores showed significant greater response for each treatment group verses placebo. 

The improvements seen in this study are interesting. It is possible that the DHEA effects were due to local metabolism to estrone (stored estrogen) and testosterone which binded to the local receptors. Considering how well drugs are absorbed through the vaginal mucosa, this is reassuring. DHEA may be considered a promising treatment alternative but further studies are needed to confirm efficacy and safety. Ideally future studies should evaluate less frequent administration of the DHEA ovule because most women may not like the daily administration. 

Reference: Davis, S. “DHEA for Urogenital Atrophy and Sexual Function.”  The North American Menopause Society e-consult, Medscape Edition. Jan, 15, 2015.

By now most of you have read about the new FDA approved drug “Addyi” used to enhance a women’s sexual drive. There’s lots of debate on whether this drug should have been approved at all.

A lobbying campaign helped push for approval of Addyi (pronounced ADD-ee) accusing the Food and Drug Administration (FDA) of gender bias for ignoring the sexual needs of women, given the many options available to men. Well…theres a problem with that statement in that Viagra, and other medications available for men are approved to help achieve erections or to treat testosterone deficiencies…not to increase sexual desire. Men don’t typically have a problem with libido (back me up here guys). Also, Sprout Pharmaceuticals, the drug maker of Addyi payed part of the expenses for the coalition (Even the Score) lobbying for approval.

Critics on the other hand, felt the advocates of the drug pressured the FDA into approving a drug that was minimally effective and had concerning side effects such as low blood pressure, fainting, dizziness, nausea, and sleepiness. Not much fun if you want to get frisky!! It is also interesting that this medication was rejected by the FDA twice, in 2010 and 2013 for the same reasons. So what changed now?  Pressure by lobbyists?  In one trial, the drug did not increase desire more than a placebo when measured by a daily diary, but did so modestly when measured by a monthly questionnaire. 

Another consideration is the price. It was decided that the price of Addyi would cost roughly the same as the monthly cost of erectile dysfunction pills. But erectile dysfunction meds are taken as needed (not daily) while Addyi is supposed to be taken at night every day. So 10 Viagra pills (average monthly use) cost about $400. You do the math…Insurance may cover it but who knows. 

The biggest barrier I found was that Addyi could only be prescribed or dispensed by doctors and pharmacists who took an on-line slide presentation and passed a test. That doesn’t seem like a lot of time, but practitioners will need to assess whether it’s more trouble than its worth? Addyi is not supposed to be used by women who drink alcohol (because it would enhance side effects) and is indicated only for pre-menopausal women. Already doctors are talking about how they would still prescribe it to “casual” drinkers, post-menopausal women and even men.  Well, which is it? 

There is some disagreement on defining normal sexual desire in women. Is it truly a problem for some women or is it a problem for their partners? Studies have shown that all types of women, both premenopausal and postmenopausal can have a low sex drive. In large women’s surveys conducted around the world, about 30% of women (even those in their teens and twenties) report a lack of sex drive (lack of thoughts about sex or desire to have sex). This is different than intimacy.

Here are the facts:

Women need several hormones in play to drive sexual desire while men need only one, which is testosterone. Research conducted on women with low sexual desire found no difference between their levels of testosterone than those women who reported healthy sex drives. But women are complex and the hormones involved include estrogen, DHEA (dehydroepiandrosterone), testosterone and oxytocin. Out of all these hormones, none is as significant as Oxytocin. This hormone makes us feel relaxed and connected to others. It is the hormone released during  breast feeding. Women with healthy levels of oxytocin have less worry and fear and accept their partners more for who they are and feel a sense of romantic attachment again. Natural ways to release oxytocin include cuddling, hugging, soft touch, massage, music, singing, physical exercise, positive social contacts and orgasm. Oxytocin releases dopamine which lights up the reward centers of the brain and helps women think of sex as something they want. This is why intimacy, romance, foreplay and making that connection turns women on! 

The other big factor is how stress plays a negative role in sex drive. Our stress hormone, Cortisol competes heavily with testosterone and inhibits the release of oxytocin. Addyi is thought to work by changing the balance of certain brain neurotransmitters like dopamine and serotonin. I give them credit in getting closer to the biochemistry of what might work, but what about women already on an antidepressant (SSRI’s) that already increases serotonin? This puts them at risk for serotonin syndrome, a severe condition causing agitation, confusion, muscle rigidity, diarrhea, headache, shivering, fever, seizures and death. 

There are still questions and concerns about this drug. I prefer to discuss the factors that influence a woman’s sex drive. Many things are involved but what I see is the stressful lifestyle that we are all trying to manage and how chronically high levels of cortisol can effect not only sex drive but all aspects of our health. Oxytocin, bio-identical testosterone and estrogen, and DHEA are all available for women if they have deficiencies to help support hormone balance. If you choose to take Addyi, which is predicted to be available starting October 17 this year, make sure you discuss all the side effects and your true risks and benefits. 

Reference:  Pollack, A. The New York Times: Health. “F.D.A. Approves Addyi, a Libido Pill for Women”. Aug 18, 2015

Hertoghe, T. “Passion Sex and Long Life: The incredible Oxytocin Adventure”. International Medical Books. Jan 2010.

Hanley, K. “Lost Your Appetite for Sex”. Whole living.com. may 2010, p. 78-80.

At one time, the only way for women to get breast cancer gene screening for the BRCA1 and BRCA2 gene tests was to be referred to a genetic counselor. She would expect to pay $4000 and find it difficult for insurance to pay for these tests due to strict criteria, often excluding women who don’t have a family history of cancer at a young age or don’t meet other requirements often defined as “high risk” for breast cancer. Unfortunately limitations included access and cost.

But now there is more affordable and accessible testing available thanks to Color Genomics, a new company founded by ex-Googlers Orthman Laraki and Elad Gil. Their company’s Color Test is a mail order, at home saliva test that costs $249 and tests 19 genes connected to breast and ovarian cancers, including the BRCA1 and BRCA2 genes. Mutations in these genes can indicate a risk for breast cancer and ovarian cancer much greater than the national average.

Women in the general population have about an 8% chance of developing breast cancer by age 70, and up to 12% by age 85. About 1.3% of American women will develop ovarian cancer. Unfortunately gene mutations put women at risk for developing cancer at a much younger age. Knowing ones risk empowers women and gives them choices in choosing between close monitoring or invasive prevention.

I know this may sound a little sketchy considering what happened with the much publicized genetic testing company 23andMe. The FDA has ordered 23andMe to stop selling genetic tests because it cannot prove it’s tests to be accurate or reliable. The difference between 23andMe and Color Genomics is that the Color Genomics Color Test needs to be ordered by a physician. Also, after a woman’s test is sent back to be analyzed, she is connected with a counselor to explain and discuss the results with her, which 23andMe never provided or recommended. At 23andMe the customer was expected to interpret and treat herself.

Color genomics is also CLIA (Clinical Laboratory Improvement Amendments) certified as are tests that already conduct physician-ordered BRCA 1 and BRCA 2 tests such as Myriad and Ambry. All 4 owners of the company have a mixed background in genetics and software. The Color Test was developed with researchers from Stanford, UCSF, and MIT and the company is working with genetic experts from U Penn, UCSF and University of Washington including a partnership with Mary-Claire King, who discovered the BRCA 1 gene.

The difference for patients is not only the convenience of at home testing but also the low cost. Color Genomics uses proprietary technology, which cuts out hours of labor of the testing process. It’s cost savings also carry over to the customer because it doesn’t work with insurance companies therefore taking the work required for insurance processing out of the picture.
You may still not want to get tested for breast or ovarian cancer genes, but to know that it’s available in a private, cost effective way can mean the difference in a life saving procedure or not.

A new diaphragm has just been FDA approved marketed as “Caya”.

The barrier diaphragm has been around since the 1960’s for many women as a contraceptive choice for those that preferred not to use birth control pills or who couldn’t use hormones due to health problems (history of blood clots, smoker, etc).

Caya is a new reengineered single-sized diaphragm with a nylon spring to fit women of different body sizes. A study enrolling 300 women was randomized to an acid-buffering contraceptive gel and to nonoxynol-9 while using this new diaphragm. A total of 35 pregnancies occurred for an overall 6-month pregnancy rate of 10.4 per 100 women. Rates were higher for the nonoxynol-9 group. Also more than half the participants reported side effects such as urogenital pain, irritation, itching, abnormal vaginal bleeding, vaginal infection and bladder infections.

The pregnancy rate of this new diaphragm is not much different than the currently available diaphragm or condom. This may be why the diaphragm has lost popularity compared to hormonal contraceptives, intrauterine devices (IUD) or progestin-implants in recent decades. 

For those women who cannot use hormonal contraceptives or the IUD, using the diaphragm WITH a condom may help contraceptive effectiveness and reduce pregnancy rates if used consistently. 

Reference: Schwartz JL et al. Contraceptive efficacy, safety, fit, and acceptability of a single-size diaphragm developed with end-user input. Obstet Gynecol 2015 Mar 5; [e-pub]. (http: // dx.doi.org/10.1097/AOG.0000000000000721)