Polycystic Ovarian SyndromePCOSNCT01607320
Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome
A study testing Raloxifene and Clomiphene in people with Polycystic Ovarian Syndrome, run by Bruce Lessey at 1 site in United States.
Trial summary
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome
- What is being tested?
- Raloxifene and Clomiphene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18 to 36
- BMI > 19 \& < 40
- PCOS diagnosis as evidenced by:
- Oligo- and/or anovulation (< 6 cycles per year) and one of the following:
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)
Who cannot join
- Use of ovulation induction agents within the past 6 months
- Positive pregnancy test before taking study medications
- History or current thromboembolic disorder
- Coronary artery disease such as heart attack or stroke
- Tobacco use or history within the past 6 months
- History of pelvic inflammatory disease and tubal factor infertility
Show all 11Show fewer
- Congenital adrenal hyperplasia
- Diabetes Mellitus
- Any subject on Metformin must "wash out" for 30 days prior to screening
- History of endometriosis
- Known male factor infertility
Trial locations and contacts
1 site in 1 country.
United States1 site
Greenville Hospital System
Greenville, South Carolina, 29605
About this study
Official title: Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
Read the detailed description
Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC
- Conditions
- Polycystic Ovarian Syndrome
- Being tested
- Raloxifene, Clomiphene
- Keywords
- PCOS, Infertility, Anovulation
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaloxifeneDrug
Also called Provera
Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
ClomipheneDrug
Also called Provera
Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Raloxifene | Experimental | 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 Receives: Drug: Raloxifene |
| Clomiphene | Active comparator | 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 Receives: Drug: Clomiphene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
Measured: 4 months
Secondary outcomes (1)
Ovulation
If ovulation does not occur during the first treatment cycle, subject will be withdrawn from study.
Measured: Cycle day 22-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Over budget, slow recruitment, and personnel change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovarian SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruce Lessey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruce Lessey, Prisma Health-Upstate
- Investigators
- Bruce A. Lessey, MD, PhD, Principal investigator, Greenville Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607320
- Sponsor's protocol ID
- 9469
- Acronym
- PCOS
- Status last verified
- Aug 2018
- First submitted
- 15 Feb 2012
- Last updated
- 20 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.
- ClinicalTrials.gov ID
- NCT01607320
- Acronym / sponsor ID
- PCOS / 9469
- Conditions
- Polycystic Ovarian Syndrome
- Keywords
- PCOS, Infertility, Anovulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Over budget, slow recruitment, and personnel change
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bruce LesseyUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 May 2012 (estimated)
- Results
- Posted 1 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
Detailed description
Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raloxifene | Experimental | Drug: Raloxifene3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 |
| Clomiphene | Active comparator | Drug: Clomiphene3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women aged 18 to 36
- BMI > 19 \& < 40
- PCOS diagnosis as evidenced by:
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)
Key exclusion criteria (11 listed)
- Use of ovulation induction agents within the past 6 months
- Positive pregnancy test before taking study medications
- History or current thromboembolic disorder
- Coronary artery disease such as heart attack or stroke
- Tobacco use or history within the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaloxifeneAlso: ProveraThirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal | Drug | Raloxifene |
| ClomipheneAlso: ProveraThirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal | Drug | Clomiphene |
Primary outcome
Pregnancy
Time frame: 4 months
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
1 secondary outcome
Ovulation
Time frame: Cycle day 22-24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A. Lessey, MD, PhD principal investigator
Greenville Hospital System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raloxifene and Clomiphene in people with Polycystic Ovarian Syndrome, run by Bruce Lessey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.