So I'm curious

C

Coqui

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Oct 14, 2004
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There was this advertisement on the radio for women who wanted to be part of a birth control study. They say they'll pay all of your medical bills out for 6 months and pay for extra stuff.

Then I got to thinking. If this is a birth control study, they obviously don't want you to use other forms of BC which would ruin their statistics. What would happen if you got pregnant during the study? Since they only pay for 6 months, what happens then?

Any other wierd questions/observations regarding clinical trials?
 
Our practice has an entire entity dedicated to clinical research and pharma trials.

If you really don't want to get pregnant then don't participate in a BC study, it's that simple as you don't know if you're getting a placebo or even if the drug works in the first place.
 
zengirl said:
Our practice has an entire entity dedicated to clinical research and pharma trials.

If you really don't want to get pregnant then don't participate in a BC study, it's that simple as you don't know if you're getting a placebo or even if the drug works in the first place.
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OMG Why don't they state that in the commercial then? There are a lot of dumb people out there breeding.
 
April23 said:
OMG Why don't they state that in the commercial then? There are a lot of dumb people out there breeding.
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I'm sure it's explained at the initial appointment, there are all kinds of waivers and stuff that need to be signed... and I know for our studies, you have to meet certain requirements to participate so it's not like anyone can take part.

It's extremely controlled.
 
Yeah I guess that makes sense zengirl. I still don't understand why they'd look for sexually active women for a placebo but I guess they're going to say, you have to sign something to make sure you can't go after them if you do get pregnant.
 
What kind of birth control study is it? What are they attempting to conclude? A side effect? The efficacy of a particular brand or type of birth control?
 
Sarcasmo said:
What kind of birth control study is it? What are they attempting to conclude? A side effect? The efficacy of a particular brand or type of birth control?
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They didn't specify in the advertisement and I'm not female otherwise I'd call.

















*looks in pants*













Yep I'm not female.
 
Coqui said:
They didn't specify in the advertisement and I'm not female otherwise I'd call.

*looks in pants*

Yep I'm not female.
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I don't think the goal of this study would be something as simple as "Use our type of birth control and see if you get pregnant or not." They tend to be pretty specific in terms of what they are attempting to identify or conclude.

For example:

Safety of Estrogens in Lupus Erythematosus - National Assessment (SELENA) is a study to test whether women with systemic lupus erythematosus (SLE or lupus) can safely use estrogen. We will determine this by looking at the effects of oral contraceptives (birth control pills, also known as "the pill") on disease activity and severity in women with SLE. The results of the study will show whether it is safe for women with SLE to use the pill.

Expected Total Enrollment: 350
Study start: June 1997; Study completion: August 2003


This study tests the effect of exogenous female hormones on disease activity and severity in women with systemic lupus erythematosus (SLE). Physicians generally do not prescribe oral contraceptives (OCs) to women with lupus because of the widely held view that these drugs can activate SLE. This practice is based on the greater incidence of SLE in women than in men, biologic abnormalities of estrogen metabolism, murine models of lupus, several anecdotes of patients having disease flares while receiving exogenous hormones, and a single retrospective study in patients with preexisting renal disease.

By contrast, recent retrospective studies suggest that the rate of flare is not significantly increased in patients taking OCs. The preexisting data is insufficient to warrant the dismissal of a potentially important birth control option in a disease that predominantly affects women in their reproductive years and whose fertility is not altered by the disease. Moreover, the use of OCs to preserve fertility in patients taking cyclophosphamide and the use of estrogens to prevent coronary artery disease and postmenopausal and steroid-induced osteoporosis are timely considerations.

We will attempt to define, in a multicenter, randomized, double-blind, placebo-controlled trial, the effect of OCs containing low-dose synthetic estrogens and progestins on disease activity in women with SLE. Because the research hypothesis is that OCs do not increase the risk of flares, we have designed the study to be able to detect minimal increases in the rate of flares in patients taking OCs.

We will enroll patients with inactive, stable, or moderate disease requiring less than 0.5 mg prednisone per kg of bodyweight per day over a 2-year period and randomize them to receive birth control pills or placebo pills for 12 months. During that time, the patient must use condoms or a diaphragm as birth control. We will recruit patients from clinics and private practices that include over 4,000 women with SLE, most belonging to minority groups.



Ages Eligible for Study: 18 Years - 39 Years
Genders Eligible for Study: Female


Inclusion Criteria:

Female
Unequivocal diagnosis of SLE
Inactive disease or be stable on 0.5 mg/kg/day or less of predisone
Must be between 18 and 39 years old if non-smoker
Must be between 18 and 35 years old if smoker

Exclusion Criteria:

Blood pressure >145/95 on three occasions
Deep vein, arterial thrombosis or pulmonary embolus
GPL >40; MPL >40; APL >50; dRVVT >37 sec
APL antibody syndrome ever
Gynecologic or breast cancer
Hepatic dysfunction or liver tumors
Diabetes mellitus (NOT due to steroids) with vascular disease
Congenital hyperlipidemia
Complicated migraine
Severe disease activity (SLEDAI >12)
Increase in SLEDAI >2 points in 3 months
Unexplained vaginal bleeding
Use of estrogen (OCP) for >1 month at any time after SLE diagnosis
Present pregnancy
Angina or MI due to APS
Age >35 yrs. for smokers; >39 yrs. for nonsmokers
 
Coqui said:
Yeah I guess that makes sense zengirl. I still don't understand why they'd look for sexually active women for a placebo but I guess they're going to say, you have to sign something to make sure you can't go after them if you do get pregnant.
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They do explain all of the risks involved prior to enrollment, at least any reputable, ethical clinic will.
 
Coqui, where do you live? I heard the exact same commercial a few weeks ago and was thinking the same thing to myself...


I wasn't even thinking about the placebo at the time though... :lol:
 
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There is no way I would consider a study like that-I've done my part towards maintaining the population, it's someone else's turn this time.
 
Zengirl, how safe are the clinical trials? I'm not interested in the patient studies, but thought about giving clinical trials a go just to get the full on exam for free and to possibly make some money while doing it. Plus I figure if they find anything wrong with me during the comprehensive exams... I can always move onto patient studies and still make money :D

I was designing a fire alarm system for a new facility for a medical research company called Quintiles and went to their website searching for some information and decided it might not be that bad of a gig...
 
They are never without risk.

Put it like this, I wouldn't do it. There's a constant supply of students willing to do it though.
 
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