Clinical trial · Interventional
Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clomiphene citrate | Drug | — | UNRESOLVED |
| raloxifene | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clomiphene
- description
- Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
- interventionNames
- Drug: clomiphene citrate
- type
- EXPERIMENTAL
- label
- Raloxifene
- description
- Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
- interventionNames
- Drug: raloxifene
Primary outcomes (1)
- measure
- Percentage of Participants With Ovulation Detected by Ultrasound
- timeFrame
- cycle day 14-20
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 38 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDDelmas PD, Bjarnason NH, Mitlak BH, Ravoux AC, Shah AS, Huster WJ, Draper M, Christiansen C. Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women. N Engl J Med. 1997 Dec 4;337(23):1641-7. doi: 10.1056/NEJM199712043372301. PMID 9385122
- BACKGROUNDBaker VL, Draper M, Paul S, Allerheiligen S, Glant M, Shifren J, Jaffe RB. Reproductive endocrine and endometrial effects of raloxifene hydrochloride, a selective estrogen receptor modulator, in women with regular menstrual cycles. J Clin Endocrinol Metab. 1998 Jan;83(1):6-13. doi: 10.1210/jcem.83.1.4448. PMID 9435408
- BACKGROUNDGrimes DA. The "CONSORT" guidelines for randomized controlled trials in Obstetrics & Gynecology. Obstet Gynecol. 2002 Oct;100(4):631-2. doi: 10.1016/s0029-7844(02)02233-0. No abstract available. PMID 12383524
- BACKGROUNDMoher D, Schulz KF, Altman D; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA. 2001 Apr 18;285(15):1987-91. doi: 10.1001/jama.285.15.1987. PMID 11308435
- BACKGROUNDAzziz R. Controversy in clinical endocrinology: diagnosis of polycystic ovarian syndrome: the Rotterdam criteria are premature. J Clin Endocrinol Metab. 2006 Mar;91(3):781-5. doi: 10.1210/jc.2005-2153. Epub 2006 Jan 17. PMID 16418211
- BACKGROUNDLessey BA, Ilesanmi AO, Lessey MA, Riben M, Harris JE, Chwalisz K. Luminal and glandular endometrial epithelium express integrins differentially throughout the menstrual cycle: implications for implantation, contraception, and infertility. Am J Reprod Immunol. 1996 Mar;35(3):195-204. doi: 10.1111/j.1600-0897.1996.tb00031.x. PMID 8962647
- BACKGROUNDLessey BA, Castelbaum AJ, Buck CA, Lei Y, Yowell CW, Sun J. Further characterization of endometrial integrins during the menstrual cycle and in pregnancy. Fertil Steril. 1994 Sep;62(3):497-506.