Libido, natinal clinical trial

AlaskaAngel · Posted: Wed Mar 30, 2005 1:43 pm Post subject: Libido, natinal clinical trial

A number of people have asked me about my perceptions of the recent clinical trial I participated in.

The testosterone clinical trial is not entirely over although it is closed to new participants, having filled its number of candidates long before expected. The coordinators were very helpful in doing whatever they could to help me participate by distance after the initial on-site physical exam and labs. The trial was 2 months in length, with each participant getting 1 jar of cream each month and not knowing which was the placebo and which had the testosterone in it, and then the next month reversing the creams. The cream was 2% testosterone and we were to use 1/8 teaspoon daily on the skin of the stomach or the thighs (fatty areas absorb in the best way). The only unpleasant aspect was that one had to put it on and then wait 5 minutes while it absorbed, which was a bit tiresome since all I wanted to do most of the time was hit the sack to sleep...

The first 2 days were a bit problematic in that the small spoon that I received was the wrong size but I wasn't sure until the third day. For whatever reason, I had 3 straight nights with a bad headache and wondered if that meant I was then getting the testosterone cream. It also seemed to me that the perineal area felt uncomfortably sensitive although I didn't feel any more libido. My husband and I started the clinical trial at the same time as a 2-week vacation so our mood was happy and we were at play.

Once a week a 1-page form with questions about various aspects had to be filled out. No, I didn't grow any more hair anywhere, or develop acne, or a deeper voice during the entire 8 weeks. At the end of each month a more detailed questionnaire had to be filled out. I also had to have lab tests periodically and send them in, so they would be able to terminate my participation if any lab came up out of range.

At the beginning of the first week of the second month I was surprised to suddenly find myself very depressed for the first 2 days. I wondered if that meant I had been on testosterone during the first month, and was coming off of it as I went into the second month and the second jar of cream. The depression ended without any problems and in fact I felt somewhat better in terms of mood for the rest of the second month than I had during the first one. At the end of the 8 weeks I filled out the last detailed form and sent it in, with my written guess that because of the sharp headache at the beginning when I accidentally started out with the wrong size spoon and dose, and because of the sudden depression at the start of the second month, I thought maybe I had been on testosterone the first month of the trial.

Not so. It turns out that the month that I was feeling the best was the month I was on the testosterone. At the end of the trial we were told that if we desired to continue to use the cream we would need to get a local provider to prescribe it, and that if we agreed then we would be contacted at the end of 6 months to provide any additional information. I don't know how many women decided to continue, but I did. It took some time to get the appointment with a local provider to get the prescription, but with the paperwork provided by the clinical trial, the cream was provided by our local small-town pharmacy without any problem. As a participant during the remaining months I am required to have blood draws every 3 months to be sure my hormonal levels remain postmenopausal. I am only a short way into the extended period now and actually I think it helps most in terms of general mood and greater energy, which then contributes to a more loving environment in general. I have no information about the results of the clinical trial pertaining to ALL of the women who participated, so this commentary on it is just my personal perspective. If and of you are interested (including doctors), I will let you know at the end what I find out and what my experience with the entire process is.
_________________
Dx Dec 2001 at age 50
Lumpectomy Jan 2002, 1.6 cm IDC plus some DCIS
Node neg
ER+, PR+, HER2+++
CAF x 6, 35 rads+boost
NED
Tamoxfen 1 3/4 yrs
In 2 clinical trials
bc for mom and 1 sis and 1 aunt and 1 granny
ovarian cancer for 1 aunt

Kristen · Experienced user Joined: 01 Nov 2004 Posts: 60

Hi Alaska...
What an interesting study, how did you manage to hook up with that study? I am glad that the cream gave you some success. I agree that just having better moods and more energy makes for better living in general. Did you talk to your onc before you went on the study? I am PR/ER + and I worry about these types of things. But, I will also say that I am suffering now in the libedo department! My energy levels are good, I weightlift and doing cardio almost everyday, but I do notice at night I crash pretty fast, but its usually a good kind of tired.
I wonder if my libedo problem stems from the flip flopping with my period and my pre-menopausal status. In Feb my GYN ran the blood test again, and it came back pre-menopausal. I pretty much thought I was considered post-menopausal after not having my period for over 15 months. Then out the clear blue sky, it returned for three months every 21 days like clock work. Now its been4 months again since I have had a period...So I am wondering if this could contribute to the libedo problem???? My husband has been patient and understanding, but it is starting to make me crazy!!
At first I didn't want to try any treatments, but I am wondering about this cream???
Kristen

leo · Owner Joined: 23 Sep 2004 Posts: 1574

Alaska,

Thanks for sharing that with us. It was really an interesting trial that was the center of attention. I think they will eventually be able to bring this product to the market, but it will take a few years...

regards,
Leo
_________________
Leonardo F - Webmaster Cancer Forums
Disclaimer: this information is for informational purposes only. It is not medical advice.

AlaskaAngel · Posted: Fri Apr 01, 2005 12:27 am Post subject: Clinical Trial

Hi Dr. Leo and Kristen,

Kristen thanks for your question. At diagnosis I wanted immediately to be part of a clinical trial, if I could find any that I felt were asking questions that were meaningful to me and that I would qualify for. I was too confused at time of diagnosis to effectively find a clinical trial for me.

Later I found the national website (ClinicalTrials.gov). I searched for any trial dealing with libido. Because of my family history I eventually got into The Early Detection for Ovarian Cancer clinical trial (and I am still in that trial, which lasts several years). But I kept watching the website for a trial dealing with libido, and last year found it. It wasn't open for a long time, but I dogged it and the day it opened I was on the phone calling. It wasn't simple. None of the locations offering the trial were near me; the closest were either Hawaii or Arizona. I had to find the money to get there and I had to pay for the physical exam and initial lab. I didn't know for sure that my labs would allow me to qualify even on the plane ride down there. Life is sometimes a gamble and I'm not really much of a gambler. But I want very much for answers to the question of post-treatment loss of libido to be worked on, instead of just being part of the problem and feeling that nobody cares as long as we are fortunate enough to be alive. I also think that some of the best answers to breast cancer will probably be found through a more thorough understanding of hormones. As with most things we don't know about, there are possible risks.

Like Leo I know it will be years yet before something is available. There are always conflicting interests in wider spheres than the realm of bc survivors when it comes to a clinical trial like this and any results.

A few other comments:

The short answer to the question "Did testosterone help with libido?" the answer is yes.

1. Before participating in the clinical trial, I found that a number of women in online discussions who had experience using testosterone mentioned that it took quite a while before they experienced good effect. The 4 weeks of the clinical trial may not be long enough to demonstrate the effect accurately either way.

2. In the late 1990's there was program on Oprah on national TV where a general group of postmenopausal women who had used the testosterone cream were explaining how helpful they had found it to be. A major difference between their use and the use in the clinical trial was that those women were using it directly on the perineal area/clitoris, whereas the clinical trial required it to be applied to the stomach and upper thighs.

3. Another difference between the effects experienced by each of the 2 groups would be that a high percentage of the group of bc survivors would likely have had a more complete transition to menopausal hormonal levels due to having had chemotherapy.

4. Another difference between the effects experienced by each of the 2 groups would be that many of the bc survivors would likely have at some time been on (and probably still are on) medication affecting hormonal levels throughout the clinical trial, such as letrozole, anastrozole, etc. in addition to having had chemotherapy.

5. Another difference in effect for some of the women in the trial may be due to which method they were using as a lubricant, and whether it included any estrogen.

So?.

Prior to starting the trial I had spent 1 3/4 years on tamoxifen and then had not been on any hormonal suppressant medication for a long period of time. At the end of the clinical trial it was the general mood and energy that are a legitimate component of libido that had improved for me.

In addition, for some time prior to the clinical trial and during the clinical trial, I was using the E-string, which dispenses a minute amount of estrogen directly to the vaginal area. Prior to the clinical trial I found that it helped somewhat but that intercourse was still quite uncomfortable and very mechanical.

What I didn?t know at the time that the 8 weeks of the clinical trial ended but since have discovered is that intercourse is now a lot less painful--even during a break from the testosterone while I was in the process of getting it prescribed in my home town. I am still using the E-string. I do not know if the testosterone "triggered" this improvement, or what. If it did, maybe I don't even need to continue the testosterone.

There still is no sexual response to breast stimulation in either breast. (I am a left lumpectomee, hanging off the edge of Stage 1.) I do feel that the increased interest I have in the physical expression of intimacy and passion is very worthwhile. No, it isn't exactly like being in the back seat of a Chevy as a teenager, but is much better for me from how I felt prior to participating in the clinical trial.

I am interested in trying an aromatase inhibitor to see what affect (if any) that may have.

AlaskaAngel

AlaskaAngel · Posted: Thu Jul 05, 2007 12:47 pm Post subject: Update, 2007

The results of the 2004 NCI study about this are available. As one of the 150 chosen to participate in this trial in 2004, I have some comments about it.

The trial was done to see if use of testosterone by breast cancer survivors would help with libido, AND to see what hormonal changes took place.

The conclusions reached were that testosterone supplementation does not help with libido AND that testosterone supplementation does NOT increase the blood levels of estradiol.

This information I think is important. Breast cancer survivors have been leery of using testosterone supplementation because the medical community believed that testosterone would break down into estradiol. So from this trial it appears clear that it does not.

One might ask what is the point, since it doesn't seem to help with libido? But I would be cautious about accepting that it does not help. Testosterone supplementation alone may not help; but this trial did not answer the question as to whether using it by balancing it with other hormones would help. As mentioned in the trial results, perhaps libido requires some amount of supplementation with estrogen. However, it also may be true that restoring libido requires some amount of testosterone as well to provide a needed balance, or it might require a balance of testosterone with other hormones such as progesterone, or even melatonin or insulin or ? So as a participant in the trial I do not accept that testosterone is "not useful in this group". The fact that use of testosterone did NOT increase the levels of estradiol is quite significant to ME.

A second point is that the trial required that the testosterone cream not be applied in the genital area. My understanding from general discussion among women who found testosterone supplementation quite useful was that they were applying it to the clitoris.

If you want to see the study results, they can be found in ASCO 2006, Abstract 8507.

-AlaskaAngel
_________________
Dx Dec 2001 at age 50
Lumpectomy Jan 2002, 1.6 cm IDC plus some DCIS
Node neg
ER+, PR+, HER2+++
CAF x 6, 35 rads+boost
NED
Tamoxfen 1 3/4 yrs
In 2 clinical trials
bc for mom and 1 sis and 1 aunt and 1 granny
ovarian cancer for 1 aunt

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