CLINICAL TRIAL STUDY LIST
Study Description Enrollment Period
2012 Vaginal Atrophy Enrolled-31
Completed evaluable pts-25
Enrollment period
September 2012
2012 Birth control Pill Enrolled-48
Completed evaluable pts.-
Enrollment period
November 2012
2012 Orgasmic Disorder Enrolled- 1
Completed evaluable pts.-
Enrollment period
July 2012
2012 Endometriosis Enrolled- 4
Completed evaluable pts.
Enrollment period
June 2012-
2012 Bacterial Vaginosis Enrolled-24
Completed evaluable pts.21
Enrollment period
June 2012- September 2012
2012 OAB Questionnaire Enrolled- 19
Completed evaluable pts.-19
Enrollment period
June 2012-July 2012
2012 Bacterial Vaginosis Enrolled- 20
Completed evaluable pts.- 20
Enrollment period
April 2012-May 2012
2012 Vaginal Atrophy Study Enrolled- 40
Completed evaluable pts- 35.
Enrollment period
April 2012- August 2012
2012 Hot flash study Enrolled-12
Completed evaluable pts.9
Enrollment period-
Dec. 2011-Feb. 2012
2011 Female Sexual Dysfunction Enrolled-12
Completed evaluable pts.11
Enrollment period-
Aug. 2011–Feb. 2012
2011 hot flash study Enrolled-6
Completed evaluable pts.3
Enrollment period-
June 2011- Sept. 2011
2011 Vaginal Atrophy study Enrolled-30
Completed evaluable pts. 24
Enrollment period-
June 2011-Dec. 2011
2011 Contraceptive Gel study Enrolled-58
Completed evaluable pts.-15
Enrollment period-
June 2011
2011 Vaginal Atrophy study Enrolled-19
Completed evaluable pts.-14
Enrollment period-
February 2011- May 2011
2011 Vaginal Atrophy study Enrolled-3
Completed evaluable pts.-2
Enrollment period-
February 2011- April 2011
2010 Nocturia study Enrolled-4
Completed evaluable pts.-3
Enrollment period-
November 2110- May 2011
2010 Bacterial Vaginosis Study Enrolled- 17
Completed evaluable pts-16
Enrollment period-
September 2010-Jan. 2011
2010 Contraceptive Patch Study Enrolled- 8
Completed evaluable pts-6
Enrollment period-
Aug. 2010-Sept.2010
2010 Contraceptive Patch Study Enrolled-51
Completed evaluable pts- 12
Enrollment period-
June 2010-Dec 2010
2010 Hot Flash Study Enrolled-8
Completed evaluable pts-5
Enrollment period-
June 2010-March 2011
2010 Bacterial Vaginosis Study Enrolled-24
Completed evaluable pts-24
Enrollment period-
February 2010- March 2010
2009 Premenopausal HSDD Enrolled -27
Completed evaluable pts.22
Enrollment period-
November 2009- June 2010
2009 Postmenopausal HSDD Enrolled - 34
Completed evaluable pts.21
Enrollment period-
November 2009-July 2010
2009 Overactive Bladder Study Enrolled- 2
Completed evaluable pts.1
Enrollment priod-
Sept. 2009- July 2010
2009 Contraceptive Patch Study Enrolled-33
Completed evaluable pts-23
Enrollment period-
June 2009-August 2009
2009 Menopause Study Enrolled-41
Completed evaluable pts.-25
Enrollment period-
March 2009- Nov. 2009
2008 birth control pill study Enrolled-2
and Dysmenorrhea Completed evaluable pts-1
Enrollment period-
Dec. 2008-
2008 Hot Flash study Enrolled-5
Completed evaluable pts.2
Enrollment period-
Nov 2008-Feb. 2009
2008 Genital Wart study Enrolled-7
Completed evaluable pts. 6
Enrollment period-
Sep 2008-Nov. 2008
2008 Over Active Bladder study Enrolled-5
Completed evaluable pts.3
Enrollment period-
May 2008- Sep.2008
2008 Hot Flash study Enrolled-27
Completed evaluable pts.15
Enrollment period-
June 2008- Nov.2008
2008 Uterine Fibroid study Enrolled- 6
Completed valuable pts.6
Enrollment period-
July 2008- Nov. 2008
2008 Vaginal Atrophy study Enrollment- 12
Completed evaluable pts.11
Enrollment period
Aug. 2008- Dec. 2008
2008 Endometrial Safety study Enrolled- 13
Completed evaluable pts.9
Enrollment period-
Jan. 2008-April 2008
2007 Intra-Uterine contraceptive device Enrolled-12
Completed evaluable pts.3
Enrollment period-
Dec. 2007-April 2007
2007 Contraceptive Patch Study Enrolled-8
Completed evaluable pts. 8
Enrollment period- Sept. 2007-
Oct. 2007
2007 Birth Control Pill Study Enrolled-7
Completed evaluable pts. 2
Enrollment period-
Dec. 2007- March 2007
2007 Decreased Libido Study Enrolled- 39
Completed evaluable pts
Enrollment period-beginning
Dec. 2007- April 2011
2007 Over Active Bladder Study Enrolled- 8
Completed evaluable pts.5
Enrollment period
Aug., 2007- Oct. 2007
2007 Non Estrogen Hot Flash Study Enrolled- 5
Completed evaluable pts. 3
Enrollment period
Aug., 2007-Jan. 2008
2007 Post Hysterectomy Libido Study Enrolled- 15
Completed evaluable pts.15
Enrollment period beginning
Aug., 2007-Nov. 2010
2007 Nocturia Study Enrolled- 6
Completed evaluable pts. 6
Enrollment period
July, 2007- Sep. 2007
2007 Hot Flash Study Enrolled-25
Completed evaluable pts. 23
Enrollment period
July, 2007-April 2008
2007 Menopausal Libido Study Enrolled-38
Completed evaluable pts.-31
Enrollment period
June, 2007-Oct 2007
2007 Endometriosis Study Enrolled-4
Completed evaluable pts.2
Enrollment period
April, 2007-Oct 2007
2007 birth control pill study Enrolled-13
Completed evaluable pts.5
Enrollment period-
June, 2007-Oct. 2007
2007 treatment of heavy bleeding Enrolled- 5
Completed evaluable pts.- 4
Enrollment period-
Feb. 2007-Nov. 2007
2006 treatment of vasomotor symptoms Enrolled- 16
Completed evaluable pts.-12
Enrollment period-
Dec. 2006-June 2007
2006female sexual arousal Enrolled- 9
Completed evaluable patients-8
Enrollment period-
Dec. 2006-April 2006
2006 Hypoactive sexual desire in Menopause Enrolled-17
Completed evaluable pts.-17
Enrollment period-
Nov. 2006- Dec. 2006
2006 Treatment of hypoactive sexual desire Enrolled-16
Completed evaluable pts.-10
Enrollment period-
September 2006-April 2007
2006 0ral contraceptive study Enrolled- 31
Completed evaluable pts.-13
Enrollment period-
Nov. 2006- March 2007
2006 Treatment of overactive bladder Enrolled-17
Completed evaluable pts.-12
Enrollment period-
Aug. 2006-Dec.2006
2006 Menorrhagia with uterine fibroids Enrolled-14
Completed evaluable pts.-10
Enrollment period-
Feb. 2006-Sept 2006
2006 Treatment of Cyclical Mastalgia Enrolled- 3
Completed evaluable pts.- 1
Enrollment period- beginning
Jan. 2006
2005 Treatment of Vaginal Atrophy Enrolled- 23
Completed evaluable pts.-19
Enrollment period-
Nov.2005-Oct 2006
2005 PMS study Enrolled- 6
Completed evaluable pts.-3
Enrollment period-
Aug. 2005-July 2006
2005Treatment of hot flashes Enrolled- 16
Completed evaluable pts.-12
Enrollment period-beginning
Aug 2005
2005 Oral Contraceptive Study Enrolled –84
Completed evaluable pts - 42
Enrollment period –
July 2005 –March 2006
2005Treatment of PMDDEnrolled – 3
Completed evaluable pts -1
Enrollment period – beginning
April 2005
2005 Treatment of Overactive BladderEnrolled - 3
Completed evaluable pts - 2
Enrollment period
April 2005- Aug 2005
2005Treatment of VaginalAtrophyEnrolled –2
Completed evaluable pts - 2
Enrollment period –
March 2005-July 2005
2005Treatment of Hot FlashesEnrolled -23
with Estrogen SprayCompleted evaluable pts –19
Enrollment period
March 2005 – Sept 2005
2004Treatment of CyclicalEnrolled – 20
Pelvic PainCompleted evaluable pts – 10
Enrollment period
Feb 2005- June 2005
2004Treatment of MenorrhagiaEnrolled –36
Completed evaluable pts -15 Enrollment period – beginning
June 2005-2006
2004Treatment of decreased Enrolled - 4
Sexual Arousal DisorderCompleted evaluable pts - 1
Enrollment period
Dec 2004- Oct.2005
2004Treatment of Vaginal Atrophy Enrolled –17
Completed evaluable pts – 14
Enrollment period
Jan 2005- July 2005
2004 Treatment of Vasomotor Enrolled -11
SymptomsCompleted evaluable pts –9
Enrollment period
Dec 2004- July 2005
2004 HPV VaccineEnrolled – 20
Completed evaluable pts -5 Enrollment period
October 2004- June 2005
2004 Yeast Vaginitis -Enrolled - 5
Evaluation of 2 oral medicationsCompleted evaluable pts - 5 Enrollment Oct2004-Feb2005
2004 Hypoactive sexual desire-Enrolled – 16
use of testosterone patchCompleted evaluable pts –12
Enrollment period – July 2004 – Sept 2004
2004 Menorrhagia with FibroidsEnrolled – 10
Completed evaluable pts – 10
Enrollment period June 2004 – Sept 2004
2004Treatment of VasomotorEnrolled – 20
symptoms of menopauseCompleted evaluable pts – 20
Enrollment period
May 2004 – Oct 2004
2004 Birth Control PillEnrolled – 38
evaluation of safety and Completed evaluable pts – 25
efficacyEnrollment period Feb 2004 – May 2004
2004Urinary Stress IncontinenceEnrolled – 11
evaluation of safety and Completed evaluable pts – 10
efficacyEnrollment period – beginning
March 2004
2004 Treatment of PostmenopausalEnrolled – 5
OsteoporosisCompleted evaluable pts – 5
Enrollment period
April 2004 – June 2004
2004Treatment of Insomnia Enrolled - 5
in menopauseCompleted evaluable pts – 2
Enrollment period
March 2004 – Oct 2004
2003 Vaginal AtrophyEnrolled - 18
Evaluation of treatmentCompleted evaluable pts – 18
Enrollment period – December 2003 – April 2004
2003 Hormone ReplacementEnrolled – 41
evaluation of treatment of Completed evaluable pts – 39
vasomotor symptoms inEnrollment period - beginning menopause September 2003 -
2003 Bacterial VaginosisEnrolled – 6
evaluating medicated Completed evaluable pts – 4
vaginal ring vs oral Enrollment period –
treatmentSeptember 03 – December 03
2003 Yeast VaginitisEnrolled - 15
evaluating differentCompleted evaluable pts - 9
vaginal suppositories forEnrollment period –treatment of yeast February 2003 – July 2003
2003 DysmenorrheaEnrolled - 68
evaluating single doseCompleted evaluable pts - 65
of medication for treatmentEnrollment period – of dysmenorrhea February 2003 – July 2003
2003 Birth Control PillsEnrolled - 46
evaluating continuousCompleted evaluable pts –24
daily regimen of BCPsEnrollment period – March 2003 – July 2003
2003Birth Control PillsEnrolled - 20
evaluating continuousCompleted evaluable pts - 15
regimen of BCPsEnrollment period –
March 2003 – July 2003
2002Bacterial VaginosisEnrolled - 21 evaluating single dose Rx Completed evaluable pts - 17 vs standard treatment for BV Enrollment period – July 2002 – June 2003
2002Contraceptive Skin PatchEnrolled –26evaluating ovulatory response Completed evaluable pts - 15 Enrollment period –
July 2002 – October 2002
2002Contraceptive Vaginal RingEnrolled - 31investigating continuous regimen Completed evaluable pts -23 Enrollment period – June 2002 - October 2002
2002Contraceptive Skin PatchEnrolled - 30 continuous vs. cyclic regimens Completed evaluable pts - 23 Enrollment period –
June 2002 - October 2002
2002Hypoactive Sexual DesireEnrolled - 24 evaluating transdermal testosterone Completed evaluable pts - 21 in naturally menopausal women Enrollment period –
June 2002 – April 2003
2002Hypoactive Sexual DesireEnrolled - 23
evaluating transdermal testosteroneCompleted evaluable pts - 20 in women having had hysterectomy & Enrollment period – beginning oophorectomy June 2002 - October 2002
2002Female Sexual DysfunctionEnrolled - 5 evaluating a testosterone gel Completed evaluable pts - 1 Enrollment period – June 2002 – January 2003
2002 Sexual Function – drug vs.Enrolled – 18
placebo for treatment of sexualCompleted evaluable pts – 6
dysfunction in womenEnrollment period – beginning
January 2002
2002PMS – evaluation of using oralEnrolled – 13
contraceptive in treatment of Completed evaluable pts - 8
premenstrual dysphoric disorderEnrollment period –
April 2002 – October 2002
2002Hormone Replacement – evaluationEnrolled – 12
of treatment of vasomotorCompleted evaluable pts – 12
symptoms in menopauseEnrollment period – April 2002 - September 2002
2001Urinary Tract Infection – a studyEnrolled – 13
comparing a once-a-day dosage ofCompleted evaluable pts – 10
antibiotics to a standard treatment.Enrollment period – August 2001- December 2001
2001Hormone Replacement – a studyEnrolled - 49
evaluating a new medication for Completed evaluable pts - 28
menopause compared to standardEnrollment period – estrogen and progesterone. November 2001 – May 2003
2001Hormone Replacement – evaluationEnrolled - 9
of treatment of vasomotorCompleted evaluable pts - 9
symptoms in menopause.Enrollment period – November 2001- July 2002
2001 Contraceptive Transdermal Patch – a Enrolled - 10 Contraceptive Transdermal Patch - a
study evaluating effect on ovulation. Completed evaluable pts - 8
Enrollment period – March 2001-
June 2001
2001Dysmenorrhea - a study evaluating Enrolled – 5
safety & efficacy of an oral contraceptive Completed evaluable pts - 4
vs. placebo on dysmenorrhea.Enrollment period -
April 2001 – June 2002
2001 Sexual Function – a validation study of theEnrolled – 16
Profile of female sexual function.Completed evaluable pts – 16
Enrollment period –
February 2001 – May 2001
2000Birth Control Pills – a study evaluatingEnrolled – 70
efficacy, cycle control & safety of a newCompleted evaluable pts – 48
birth control pill vs. a current one on theEnrollment period – Sept 2000 -
market.March 2001
2000Cervical Dysplasia – a study evaluatingEnrolled – 6
safety & efficacy of a treatment for low-Completed evaluable pts – 5
grade cervical dysplasiaEnrollment period – March 2000 –
August 2000
2000Sexual Function – a study comparingEnrolled – 36
patients with normal sexual function withCompleted evaluable pts – 32
those having had a hysterectomy who have Enrollment period – January 2000 –
decreased libidoApril 2000
1999Hormone Replacement – a study evaluatingEnrolled – 17
safety & efficacy of a hormone-containingCompleted evaluable pts – 15
intravaginal ringEnrollment period – November 1999 –
May 2000
1999Dysmenorrhea – a study evaluating Enrolled – 4
safety & efficacy of an oral contraceptiveCompleted evaluable pts – 2
on dysmenorrheaEnrollment period – October 1999 –
December 1999
1999Irritable Bowel Syndrome- a studyEnrolled – 8
evaluating the safety & efficacy of anCompleted evaluable pts – 7
oral medication for control of bowelEnrollment period – October 1999 –
urgencyJanuary 2000
1998Herpes – a study evaluatingEnrolled – 18
safety & efficacy of an oral drug forCompleted evaluable pts – 10
recurrent genital herpesEnrollment period – October 1998 –
February 1999
1998Vaginitis – phase III study comparingEnrolled – 11
single dose vaginal cream to a 7-dayCompleted evaluable pts –8
cream treatment for vulvovaginal candidiasisEnrollment period – May 1998 -
September 1998
1997Contraceptive Vaginal Ring – studyEnrolled – 38
evaluating the safety & efficacyCompleted evaluable pts – 21
of ring.Enrollment period – November 1997 -
March1998
1997Transdermal Contraceptive System – aEnrolled – 66
study evaluating safety & efficacy inCompleted evaluable pts – 42
comparison to an oral contraceptiveEnrollment period – December 1997-
May 1998
1997Hormone Replacement – evaluation ofEnrolled – 19
effects of combined estrogen and progestinCompleted evaluable pts – 11
patch on endometrial hyperplasiaEnrollment period – August 1997 –
July 1998
1997Vaginitis – phase III study comparing a singleEnrolled – 16
dose vaginal ovule to a 7-day cream treatmentCompleted evaluable pts – 14
for vulvovaginal candidiasisEnrollment period – May 1997 –
November 1997
1997Birth Control Pills – a study evaluating severalEnrolled – 99
cyclophasic pills for safety & efficacyCompleted evaluable pts – 76
Enrollment period – April 1997 –
November 1997
1996Vaginitis – phase III study comparing 3, 5 andEnrolled – 19
7-day treatment for vulvogaginal cadidiasisCompleted evaluable pts – 14
Enrollment period – July 1997 –
November 1997
1996 Hormone Replacement –evaluation of Enrolled –9
treatment of vasomotor symptoms inCompleted evaluable pts –9
menopauseEnrollment period – September 1996 –
May1997
1995Birth Control Pills – comparing lower dosesEnrolled – 63
of triphasic preparations of 6 monthCompleted evaluable pts – 53
durationEnrollment period – January – July 1995
1993Vaginitis – comparing different treatmentsEnrolled – 7
for bacterial vaginosisCompleted evaluable pts – 4
Enrollment period – March – April 1993
1992-93Vaginitis – further clinical trials to meetEnrolled – 32
FDA requirements to be OTC in treatmentCompleted evaluable pts – 22
of yeast vaginitisEnrollment period – November 1992 –
June 1993
1992 Birth Control Pills – study comparing Enrolled – 31
formulations of new progestin pillCompleted evaluable pts- 19
Enrollment period – March – August 1992
1988-89 Birth Control Pills – study comparingEnrolled – 40
formulations of new progestin pillCompleted evaluable pts- 28
Enrollment period – May 1998 –
February 1989