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A closer look at how ORIAHNN was studied
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What is ORIAHNN?
ORIAHNN™ is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.
Please see Use and Important Safety Information for ORIAHNN at the end of this video.
Please see Full Prescribing Information, including Medication Guide for ORIAHNN, on Oriahnn.com.
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SAFETY CONSIDERATIONS
ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, and/or are obese. Stop taking ORIAHNN and talk to a doctor right away if you have symptoms of a heart attack, stroke, or blood clot.
Please see Use and Important Safety Information for ORIAHNN at the end of this video.
Please see Full Prescribing Information, including Medication Guide for ORIAHNN, on Oriahnn.com.
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How was ORIAHNN proven to work in clinical trials?
NAOMI:
How was ORIAHNN proven to work? I can show you how it worked for women in clinical trials…
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ORIAHNN lightened heavy periods for about 7 in 10 women
*In two 6‐month clinical trials of pre‐menopausal women aged 25‐53 with heavy periods due to fibroids, about 7 in 10 women taking ORIAHNN had lighter periods at final month of treatment vs about 1 in 10 women taking placebo.
NAOMI:
because I was one of them! Hi! I’m Naomi.
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ONE OF MILLIONS
NAOMI:
One of millions of women with uterine fibroids. My gynecologist said one option to treat my heavy bleeding was surgery.
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SURGERY?
NAOMI:
But I wasn’t sure I wanted that right now.
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NON-SURGICAL OPTION
NAOMI:
I was looking for a non‐surgical option. So when she told me about the clinical trials for ORIAHNN to manage heavy menstrual bleeding due to uterine fibroids, I definitely wanted to take part.
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Who took part in the trials?
NAOMI:
Let’s see who else participated.
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Age: 25 to 53
NAOMI:
There were two 6-month clinical trials for ORIAHNN, which included 790 women aged 25 to 53 who were diagnosed with uterine fibroids.
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Weight: 108 lbs to 355 lbs
Race: 68% African American
29% Caucasian
3% Other
NAOMI:
The women varied in weight and race. Some had children and some did not.
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Amount of menstrual bleeding at start of trials
=about 1/3 cup
84 mL
Lowest
NAOMI:
At the start of the trials, menstrual bleeding ranged from 84 milliliters…
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Amount of menstrual bleeding at start of trials
=about 1 cup
240 mL
Average
NAOMI:
…to an average of 240 milliliters…
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Amount of menstrual bleeding at start of trials
=about 5 cups
1207 mL
Highest
NAOMI:
…to 1207 milliliters per period, which could mean a lot of pads and tampons!
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How did scientists know how much menstrual blood women lost?
NAOMI:
How did scientists know how much menstrual blood women lost? They measured it. Each month, we had to bring in all our used pads and tampons. Scientists then measured how much blood was on each of the supplies to see if our bleeding was reduced. To prove if ORIAHNN really worked, they split us into groups. One group took ORIAHNN. The other group took a placebo, which is a pill that doesn’t have any medicine in it.
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Pills were taken each morning and evening.
NAOMI:
We didn’t know which group we were in. We just took our pills daily, for 6 months, bringing in our used pads and tampons each month to measure our bleeding.
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What were the results of the clinical trials?
NAOMI:
What were the results of the clinical trials? ORIAHNN did lighten heavy periods.
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ORIAHNN
~7 in 10 HAD LIGHTER PERIODS
Lighter periods defined as at least 50% reduction from start of trial and to below 80 mL at final month of treatment.
NAOMI:
At the final month, about 7 in 10 women who took ORIAHNN had lighter periods.
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PLACEBO
~1 in 10 HAD LIGHTER PERIODS
Lighter periods defined as at least 50% reduction from start of trial and to below 80 mL at final month of treatment.
NAOMI:
On the other hand, about 1 in 10 women taking placebo showed that improvement.
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ORIAHNN |
Start of Trial |
Month 1 |
|
|
51% Reduction |
Results from Trial 2. Trial 1 results were similar.
NAOMI:
On average with ORIAHNN, periods at the first monthly check-in were reduced by 122 milliliters. That’s 51% less than at the start of the trial.
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ORIAHNN |
Start of Trial |
Month 1 |
PLACEBO |
Start of Trial |
Month 1 |
Results from Trial 2. Trial 1 results were similar.
NAOMI:
By comparison, women taking placebo had an average reduction of 16 milliliters, or about 5%.
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ORIAHNN |
Start of Trial |
Month 1 |
Month 3 |
Month 6 |
PLACEBO |
Start of Trial |
Month 1 |
Month 3 |
Month 6 |
Results from Trial 2. Trial 1 results were similar.
NAOMI:
Average bleeding reductions for women taking ORIAHNN were also lighter at months 3 and 6 of the trials.
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Start of Trial |
Month 1 |
Month 3 |
Month 6 |
89% (-188 mL) Reduction
Results from Trial 2. Trial 1 results were similar.
Women taking placebo averaged an increase of 9% (+12 mL) at month 6.
NAOMI:
Overall, from the start of my trial to Month 6, the average bleeding reduction was 188 milliliters or 89%.
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Most Common Side Effects |
ORIAHNN |
PLACEBO |
Hot flashes |
22% |
9% |
Headache |
9% |
7% |
Fatigue (tiredness) |
6% |
4% |
Irregular periods |
5% |
1% |
These side effects were reported in 5% or more of women and at a greater percentage than placebo. These are not all the possible side effects of ORIAHNN.
NAOMI:
The most common side effects reported in the clinical trials were hot flashes, headache, fatigue, and irregular periods. In the clinical trials, ORIAHNN lightened heavy periods due to uterine fibroids for the majority of us. Lighter periods could be possible for you too.
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SHARE
NAOMI:
Ask your gynecologist if ORIAHNN is right for you. And share this video with the women in your life who have heavy menstrual bleeding due to uterine fibroids.
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ORIAHNN logo
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