A randomized, controlled trial of asoprisnil, a novel selective progesterone receptor modulator, in women with uterine leiomyomata.

Abstract:

OBJECTIVE:To determine efficacy and safety of asoprisnil in patients with leiomyomata. DESIGN:Phase 2, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study. SETTING:Twenty-eight sites in the United States and 1 in Canada. PATIENT(S):One hundred twenty-nine women with leiomyomata. INTERVENTION(S):Asoprisnil (5, 10, or 25 mg) or placebo orally daily for 12 weeks. MAIN OUTCOME MEASURE(S):Uterine bleeding changes by using daily bleeding diaries, hemoglobin concentrations, dominant leiomyoma and uterus volume measured sonographically, patient-reported symptoms related to bloating and pelvic pressure, endometrial thickness and morphology, hormonal parameters, and standard safety measures. RESULT(S):Asoprisnil suppressed uterine bleeding in 28%, 64%, and 83% of subjects at 5, 10, and 25 mg, respectively, and reduced leiomyoma and uterine volumes. Median percentage decrease from baseline in leiomyoma volume was statistically significant at 25 mg compared with placebo after 4 and 8 weeks of treatment; by week 12, leiomyoma volume was reduced by 36%. There was a significant reduction in bloating with the two highest doses and in pelvic pressure with 25 mg by week 12. Asoprisnil was associated with follicular-phase estrogen concentration and minimal hypoestrogenic symptoms. CONCLUSION(S):After 12-week treatment, asoprisnil controlled uterine bleeding while reducing leiomyoma volume and the associated pressure symptoms. Asoprisnil was well tolerated.

journal_name

Fertil Steril

journal_title

Fertility and sterility

authors

Chwalisz K,Larsen L,Mattia-Goldberg C,Edmonds A,Elger W,Winkel CA

doi

10.1016/j.fertnstert.2006.11.094

subject

Has Abstract

pub_date

2007-06-01 00:00:00

pages

1399-412

issue

6

eissn

0015-0282

issn

1556-5653

pii

S0015-0282(06)04533-X

journal_volume

87

pub_type

杂志文章,多中心研究,随机对照试验
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    authors: Kremer JA,Rolland R,van der Heijden PF,Thomas CM,Lancranjan I

    更新日期:1989-04-01 00:00:00

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    doi:10.1016/s0015-0282(98)00204-0

    authors: Pellicer A,Albert C,Mercader A,Bonilla-Musoles F,Remohí J,Simón C

    更新日期:1998-09-01 00:00:00

  • Recommended practices for the management of embryology, andrology, and endocrinology laboratories: a committee opinion.

    abstract::This document provides a general overview for physicians of the qualities and conditions necessary for good management practices within the endocrinology, andrology, and embryology laboratories in the United States. It is intended as an addendum to previously published guidelines that further detail these responsibili...

    journal_title:Fertility and sterility

    pub_type: 杂志文章,实务指引,评审

    doi:10.1016/j.fertnstert.2014.06.036

    authors: Practice Committee of the American Society for Reproductive Medicine.,Practice Committee of the Society for Assisted Reproductive Technology.,Practice Committee of the Society of Reproductive Biologists and Technologists.

    更新日期:2014-10-01 00:00:00

  • Ovarian and adrenal vein steroids in patients with nonneoplastic hyperandrogenism: selective catheterization findings.

    abstract::Standardized bilateral ovarian-adrenal vein catheterization was utilized to assess directly glandular steroid release in 60 androgenized women without evidence of a functional neoplasm. Testosterone (T), dihydrotestosterone (DHT), androstenedione (delta 4 A), dehydroepiandrosterone (DHEA), DHEA sulfate (DHEA-S), 17-hy...

    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)47960-4

    authors: Moltz L,Schwartz U,Sörensen R,Pickartz H,Hammerstein J

    更新日期:1984-07-01 00:00:00

  • A prospective, randomized study of pregnancy rates after transuterotubal and intrauterine insemination.

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    journal_title:Fertility and sterility

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Oei ML,Surrey ES,McCaleb B,Kerin JF

    更新日期:1992-07-01 00:00:00

  • Unilateral triplet ectopic pregnancy after in vitro fertilization and embryo transfer.

    abstract:OBJECTIVE:To present a case report of a unilateral triplet ectopic pregnancy (EP) conceived by IVF-embryo transfer. DESIGN:Case report. SETTING:University Hospital, Budapest, Hungary. PATIENT(S):A 26-year-old infertile woman with a history of right salpingectomy, hyperprolactinemia, and male factor infertility under...

    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/j.fertnstert.2008.03.018

    authors: Berkes E,Szendei G,Csabay L,Sipos Z,Joo JG,Rigo J Jr

    更新日期:2008-11-01 00:00:00

  • Culturing human embryos with and without glucose.

    abstract:OBJECTIVE:To review published data and to compare pregnancy rates (PRs) after culturing human embryos with and without glucose and phosphate. DESIGN:Comparison of results from various programs. SETTING:Assisted Reproductive Technology Program. PATIENT(S):Patients were enrolled in various studies. INTERVENTION(S):Hu...

    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(98)00052-1

    authors: De Silva M

    更新日期:1998-05-01 00:00:00

  • Effective treatment of severe menstrual migraine headaches with gonadotropin-releasing hormone agonist and "add-back" therapy.

    abstract:OBJECTIVE:To determine the efficacy of treating women with severe menstrual migraine headaches with GnRH agonist (GnRH-a) therapy, alone and combined with continuous estrogen-progestin "add-back." DESIGN:Nonrandomized, prospective treatment study. SETTING:Outpatient clinic in a university medical center. PATIENT(S):...

    journal_title:Fertility and sterility

    pub_type: 临床试验,杂志文章

    doi:10.1016/S0015-0282(97)81928-0

    authors: Murray SC,Muse KN

    更新日期:1997-02-01 00:00:00

  • Induction of menstruation by an antiprogesterone steroid (RU 486) in primates: site of action, dose-response relationships, and hormonal effects.

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)47246-8

    authors: Healy DL,Baulieu EE,Hodgen GD

    更新日期:1983-08-01 00:00:00

  • Effects of ovarian puncture for in vitro maturation on subsequent in vitro fertilization cycle in women with polycystic ovaries.

    abstract::We conducted a case-control study and compared the results of IVF treatment in two groups of women with polycystic ovaries. The first group consisted of 42 women who were previously treated unsuccessfully with in vitro maturation (IVM), and the second group, 48 others with no previous IVM (control group). We included ...

    journal_title:Fertility and sterility

    pub_type: 信件

    doi:10.1016/j.fertnstert.2009.09.033

    authors: Agdi M,Zarei A,Al-Sannan B,Tulandi T,Tan SL

    更新日期:2010-06-01 00:00:00

  • Female dietary antioxidant intake and time to pregnancy among couples treated for unexplained infertility.

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    journal_title:Fertility and sterility

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.fertnstert.2013.11.008

    authors: Ruder EH,Hartman TJ,Reindollar RH,Goldman MB

    更新日期:2014-03-01 00:00:00

  • Controlled trial of high spermatic vein ligation for varicocele in infertile men.

    abstract:OBJECTIVE:To determine whether high ligation is an effective treatment for infertile men with clinical varicocele. DESIGN:A randomized, controlled trial of high spermatic vein ligation was carried out. The patients were treated and observed for 3 years. SETTING:Infertility treatment clinic and andrology laboratory in...

    journal_title:Fertility and sterility

    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:10.1016/s0015-0282(16)57306-3

    authors: Madgar I,Weissenberg R,Lunenfeld B,Karasik A,Goldwasser B

    更新日期:1995-01-01 00:00:00

  • Circannual rhythms of sperm parameters of fertile men.

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)60738-0

    authors: Saint Pol P,Beuscart R,Leroy-Martin B,Hermand E,Jablonski W

    更新日期:1989-06-01 00:00:00

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/j.fertnstert.2005.05.069

    authors: Zech NH,Netzbandt P,Zech H

    更新日期:2005-12-01 00:00:00

  • Gonadal structures in a fetus with complete androgen insensitivity syndrome and persistent Müllerian derivatives: comparison with normal fetal development.

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/j.fertnstert.2010.09.028

    authors: Corbetta S,Muzza M,Avagliano L,Bulfamante G,Gaetti L,Eller-Vainicher C,Beck-Peccoz P,Spada A

    更新日期:2011-03-01 00:00:00

  • A randomized trial of letrozole versus clomiphene citrate in women undergoing superovulation.

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    journal_title:Fertility and sterility

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1016/j.fertnstert.2004.04.070

    authors: Al-Fozan H,Al-Khadouri M,Tan SL,Tulandi T

    更新日期:2004-12-01 00:00:00

  • In vitro fertilization in couples with male factor infertility.

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)49338-6

    authors: Hirsch I,Gibbons WE,Lipshultz LI,Rossavik KK,Young RL,Poindexter AN,Dodson MG,Findley WE

    更新日期:1986-05-01 00:00:00

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(97)81509-9

    authors: Hock DL,Bohrer MK,Ananth CV,Kemmann E

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)57844-3

    authors: Goldenberg M,Sivan E,Sharabi Z,Bider D,Rabinovici J,Seidman DS

    更新日期:1995-10-01 00:00:00

  • The hyperandrogenic-insulin-resistant acanthosis nigricans syndrome: therapeutic response.

    abstract::The hyperandrogenic-insulin-resistant acanthosis nigricans syndrome affects between 2% and 5% of hirsute women and is characterized by INS resistance, elevated INS levels, acanthosis nigricans, and androgen excess. These patients' response to therapy is unclear, although long-acting GnRH-a suppression has been propose...

    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:

    authors: Azziz R

    更新日期:1994-03-01 00:00:00

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    pub_type: 临床试验,杂志文章

    doi:10.1016/s0015-0282(16)58447-7

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    更新日期:1996-08-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)38224-3

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    更新日期:1971-05-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1016/j.fertnstert.2015.10.027

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    更新日期:2016-02-01 00:00:00

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    journal_title:Fertility and sterility

    pub_type: 杂志文章,多中心研究,随机对照试验

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:

    authors: Trifunac NP,Bernstein GS

    更新日期:1981-03-01 00:00:00

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)41769-3

    authors: Jones GS

    更新日期:1976-04-01 00:00:00

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    journal_title:Fertility and sterility

    pub_type: 杂志文章,评审

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:10.1016/s0015-0282(16)54562-2

    authors: Koonings PP,al-Marayati L,Schlaerth JB,Lobo RA

    更新日期:1991-09-01 00:00:00

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    journal_title:Fertility and sterility

    pub_type: 杂志文章

    doi:

    authors: Billups KL,Tillman SL,Chang TS

    更新日期:1990-06-01 00:00:00