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Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

This study has been completed.
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre Identifier:
First received: January 26, 2007
Last updated: August 15, 2016
Last verified: August 2016

The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity.

Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation.

The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.

Condition Intervention Phase
Polycystic Ovary Syndrome
Drug: clomiphene citrate
Drug: raloxifene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome

Resource links provided by NLM:

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Percentage of Participants With Ovulation Detected by Ultrasound [ Time Frame: cycle day 14-20 ]
    Ovulation detected by ultrasound was defined as the percentage of a participants with ovulation detected by ultrasound, defined as the dominant follicle and its subsequent collapse. If a dominant follicle was not observed by day 21 after menses, the ovulation induction was considered to be a failure.

Secondary Outcome Measures:
  • Serum Levels of Progesterone [ Time Frame: 8-10 days after ovulation ]
    The level of serum progesterone that indicated ovulation was considered to be 3 ng/mL or greater, on days 8 to 10 after ovulation.

Enrollment: 82
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clomiphene
Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
Drug: clomiphene citrate
100mg PO on days 5-9 of the menstrual cycle
Other Name: Clomid
Experimental: Raloxifene
Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
Drug: raloxifene
100mg PO on days 5-9 of the menstrual cycle
Other Name: Evista

  Show Detailed Description


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All patients with polycystic ovarian syndrome will be invited to participate in the study. The PCOS criteria are according to modified Rotterdam criteria (7); i.e., oligoovulation defined as < 6 menstrual periods per year, signs of clinical hyperandrogenism (Ferriman and Gallwey >8) or laboratorial (total Testosterone >=0.81 ng/dL) or polycystic ovary > 10cm3.

Furthermore, all patients with infertility diagnosis based solely on ovulation factor will included in the protocol

  • Age >18 years old and <= 38 years old.
  • No endometriosis on laparoscopy

Exclusion Criteria:

  • Not willing to participate in the study
  • use of IUD or contraceptive pill within 2 months before the study.
  • Hyperprolactinemia (>20ng/mL)
  • Abnormal serum levels of TSH(normal range:0.4-40 mUI/mL).
  • High 17-OH progesterone (>=4.9ng/mL)
  • Endometriosis
  • Known allergy to clomiphene or raloxifene
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00427700

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Principal Investigator: Ricardo F Savaris, MD, PhD Hospital de Clínicas de Porto Alegre
Study Chair: Helena Corleta, MD, PhD Hospital de Clínicas de Porto Alegre
Study Director: Bruce A Lessey, MD, PhD Greenville Hospital System
  More Information


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre Identifier: NCT00427700     History of Changes
Other Study ID Numbers: RACLO
Study First Received: January 26, 2007
Results First Received: November 21, 2014
Last Updated: August 15, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Hospital de Clinicas de Porto Alegre:
Polycystic Ovary Syndrome
clomiphene citrate

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Raloxifene Hydrochloride
Citric Acid
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Calcium Chelating Agents
Chelating Agents processed this record on May 25, 2017