8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

FORM 8-K

Current Report Filed Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report

(Date of earliest event reported): December 27, 2010

Repros Therapeutics Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-15281	76-0233274
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)
2408 Timberloch Place, Suite B-7 The Woodlands, Texas  77380 (Address of principal executive offices and zip code)
	(281) 719-3400 (Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

[  ]           Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]           Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]           Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]           Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01  Other Events.

On December 27, 2010, Repros Therapeutics Inc. (the “Company”) issued a press release titled “Vaginal Delivery of Repros’® Proellex® Bypasses First Pass Liver Effects and Achieves Greater Signals of Efficacy at Significantly Lower Exposure.”

On December 28, 2010, the Company issued a press release titled “Reanalysis by Outside Statistician Shows Androxal® Provides Statistically Significant Improvement in Testosterone Levels in Men with Male Hormone Levels ≤ 250 ng/dL.”

Copies of such press releases are attached hereto as Exhibit 99.1 and Exhibit 99.2 and are incorporated herein by reference.

Item 9.01  Financial Statements and Exhibits.

(d)  Exhibits.

Exhibit
Number	Description
99.1	Press Release dated December 27, 2010

99.2  Press Release dated December 28, 2010

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Repros Therapeutics Inc.
Date:  December 28, 2010
	By:	/s/ Joseph S. Podolski
		Joseph S. Podolski
		President and Chief Executive Officer

EXHIBIT INDEX

Exhibit
Number	Description
99.1	Press Release dated December 27, 2010

99.2  Press Release dated December 28, 2010

EX-99.1

Exhibit 99.1

Contact: Repros Therapeutics Inc.

Joseph Podolski (281) 719-3447

President and Chief Executive Officer

VAGINAL DELIVERY OF REPROS’® PROELLEX® BYPASSES FIRST PASS LIVER EFFECTS AND ACHIEVES GREATER SIGNALS OF EFFICACY AT SIGNIFICANTLY LOWER EXPOSURE

Company plans to submit new IND to FDA pending vaginal irritation study

THE WOODLANDS, Texas – December 27, 2010 – Repros Therapeutics Inc.® (NasdaqCM:RPRX) today announced it has completed two animal model studies of the use of Proellex® in a vaginally administered formulation that demonstrated effects on progesterone sensitive tissues equivalent to the highest oral dose formerly in development by the Company.  Most importantly, extrapolating the data from the exposure seen in animals to that seen in humans, administration of Proellex via the vaginal route may achieve maximum circulating concentrations that are approximately 2% of that exhibited in humans at the 50 mg dose and only 6.5% of the lowest oral dose, 12.5 mg, previously tested in humans.

The Company believes the high concentrations of the active ingredient and its primary metabolite attained in first pass absorption and processing by the liver resulted in the delayed toxicity exhibited in roughly 3-4% of the women administered the 50 mg dose of the drug in Phase III studies.  At 12.5 mg there were no adverse liver toxicity signals different than placebo.  The maximum concentrations of parent and metabolite for the 12.5 mg dose were 25% of the 50 mg dose.

The Company’s first animal study was conducted in dogs comparing a vaginal formulation to the oral formulation used in the Repros studies.  Maximum circulating concentrations of the active ingredient and the metabolite in the vaginal formulation were roughly 6.5% of the values obtained via the oral route for the same dose of the drug.

To determine whether these low circulating levels could have any impact predictive of efficacy, the Company conducted a study in rabbits.  The rabbit study, known as the “anti-Clauberg” assay is used as a model to determine the efficacy potential of drugs such as Proellex.  The model was originally used by the National Institute of Health in selecting the active ingredient of Proellex as the lead compound from the family of molecules they discovered and exclusively licensed to Repros.  The data from the study showed that vaginal delivery of Proellex exhibits four times the activity of the same oral dose.  Coupling the findings of the dog study with this outcome suggests a highly efficacious and safe formulation of Proellex may be developed.  The Company is completing one more dose optimization study in the rabbit and pending that outcome will conduct a vaginal irritation study before requesting a pre-IND meeting with the FDA.  The Company plans to submit its findings for publication.  A patent application is pending that covers this technology.  The formulation uses standard pharmaceutical excipients that have previously shown to be devoid of properties that would irritate the vagina.

Joseph S. Podolski, President and CEO of Repros, commented, “The animal data is impressive. If we can obtain agreement from the FDA to conduct a study of vaginally administered Proellex in the second quarter of 2011, we can be in a position to compare low dose oral administration to vaginal administration by year end.”  He further noted, “Though our Phase III studies of high oral doses were stopped due to liver toxicity, the insight we gained from conducting those studies is invaluable.  We believe we will be able to move to Phase III after we complete these studies pending favorable outcomes.”

About Repros Therapeutics Inc.

Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to have the partial hold on Proellex® lifted and to determine a safe and effective dose for Proellex,  raise needed additional capital on a timely basis in order for it to continue to fund its operations and pursue its development activities, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company's website at http://www.reprosrx.com.

EX-99.2

Exhibit 99.2

Contact: Repros Therapeutics Inc.

Joseph Podolski (281) 719-3447

President and Chief Executive Officer

REANALYSIS BY OUTSIDE STATISTICIAN SHOWS ANDROXAL® PROVIDES STATISTICALLY SIGNIFICANT IMPROVEMENT IN TESTOSTERONE LEVELS IN MEN WITH MALE HORMONE LEVELS ≤ 250 ng/dL

 FDA recommends men with morning testosterone ≤ 250 ng/dl should

be studied in Phase IIb trial

THE WOODLANDS, Texas – December 28, 2010 – Repros Therapeutics Inc.® (NasdaqCM:RPRX) today reported it has submitted to the FDA a reanalysis of the previously completed 200 subject trial ZA-003 of Androxal® in the treatment of secondary hypogonadism as noted by Repros in the Company’s press release of November 9, 2010.  The Company contracted an outside statistician, Tony Orlando, Ph.D, V.P., Global Data Division, Pharm-Olam International Ltd. to conduct the analysis.

Dr. Orlando performed several different analyses.  He first assessed the subset of men in the 003 study that exhibited morning testosterone levels ≤ 250 ng/dl to mimic the upcoming Phase IIb study.  He examined the data for the men after three months of treatment and again for those that completed the six month study.  There were 11, 16, 20 and 21 men in the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups, respectively, that met the baseline testosterone criteria and completed three months of the study. After three months of treatment the mean change from baseline in morning testosterone levels for the four groups were 216.8, 260.5, 213.6 and 50.1 ng/dl for the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups, respectively.  Even with the small number of men in this subset, both doses of Androxal achieved statistically significant changes from baseline results when compared to placebo (p=0.0001 @ 25 mg and 0.0021 @ 12.5 mg).  For the men from this group that remained in the study for the full six month period, changes from baseline levels as compared to placebo remained significant (p<0.01).

Dr. Orlando also performed a “completer” analysis for all the men in the study.  Now with roughly 33 to 37 men per group, he observed that mean changes of morning testosterone for the four groups from baseline to after six months of treatment were 139.4, 271.5, 132.3 and 12.5  ng/dl for the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups respectively. Both of the Androxal groups exhibited p values < 0.0001 compared to placebo.  Mean testosterone levels after the six month study were 410.4 at 12.5 mg and 519.3 at 25 mg Androxal.

As part of Dr. Orlando’s analyses he also looked at the impact of Androxal and Androgel on luteinizing hormone (LH) and follicle stimulating hormone (FSH) in the men with baseline morning testosterone ≤ 250 ng/dl.  Androxal significantly increased LH levels in a dose dependent manner.  LH stimulates the testes to produce testosterone.  Androxal also significantly increased FSH in a dose dependent manner.  FSH stimulates the testes to produce sperm.  He further determined that there was a statistically significant correlation between changes in LH and changes in morning testosterone level (correlation = 0.6137, p value <0.0001).  This analysis underscores the mode of action of Androxal which restores pituitary responsiveness to low circulating levels of testosterone, in turn stimulating the testes to produce normal levels of testosterone in a normal rhythmic pattern.

Conversely, Androgel significantly reduced pituitary secretions of both LH and FSH which further suppressed testicular function, and causes variability in testosterone levels not corresponding to the normal rhythmic pattern observed in healthy males.

One of the safety assessments proposed by the FDA that will be made in the planned Phase IIb study is to assess the impact of Androxal compared to placebo and Testim (an approved topical testosterone preparation) upon the reproductive status of men receiving three months of treatment with the study drugs.  Dr. Orlando also observed that over 62% of men on Androgel in the analysis of the 003 study exhibited FSH levels below the lower limit of normal (1.4 mIU/ml) after three months of Androgel treatment, and noted that over 43% of those men had FSH levels below the lower limit of detection 0.3 mIU/ml.  In a previous proof of principle study conducted by Repros it was found that roughly 80% of men with FSH levels less than 2.0 exhibited sperm parameters that would be considered sub fertile.  After three months of treatment all men on the 25 mg dose of Androxal had FSH levels above 1.4 mIU/ml (minimum observed 2.9).

Joseph S. Podolski, President and CEO of Repros commented, “We believe Dr. Orlando’s observations bode well for our upcoming Phase IIb study and further reinforce the findings from our previous studies.”  He further stated, “Unlike testosterone replacement therapy, Androxal treats the underlying defect that is the reason for low testosterone levels in the majority of men that experience this condition.  Androxal normalizes testicular function, improving testosterone levels back into the normal range, and maintains a man’s reproductive status.”

About Repros Therapeutics Inc.

Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Repros' ability to have success in its clinical trial programs, raise needed additional capital on a timely basis in order for it to continue to fund its operations and pursue its development activities, and such other risks which are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please visit the Company's website at http://www.reprosrx.com.