InfertilityPhase 3NCT00610077
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
A Phase 3 study testing Letrozole and Clomiphene citrate in people with Infertility, run by Sun Pharmaceutical Industries Limited at 1 site in India.
Trial summary
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Letrozole and Clomiphene citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2004to Jul 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females with anovulatory infertility 20-38 years of age.
- Diagnosis of anovulatory infertility as established by standard criteria.
- Normal Pelvic USG and bilateral tubal patency
- Willingness and giving written Informed Consent.
Who cannot join
- Uterine and adnexal pathology e.g. leiomyomata
- Ovarian cyst
- Hyperprolactinaemia
- Hyperthyroidism or Hypothyroidism*
- FSH >9mIU/ml (during early follicular phase).* (As per Chemoluminescence method)
- Previous surgery related to genital tract as per history
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- Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy
- Impaired hepatic /renal function
- Diabetes mellitus/Random blood sugar- > 140mg/dl
- Drugs likely to interfere with ovulation
- Alcohol intake as per history
- History of hypersensitivity to the study drug or to its excipients
- Planned travel outside the study area for a substantial portion (>5 days) of the study period by potential participants
- Lack of willingness to give informed written consent
- Participation in any clinical study within the preceding 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.
Read the detailed description
MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.
- Conditions
- Infertility
- Being tested
- Letrozole, Clomiphene citrate
- Keywords
- Letrozole, Clomiphene citrate, Anovulatory infertility, Ovulation induction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Letroz
Tablet Letrozole 2.5 mg once a day for 5 days for 3 cycles
Clomiphene citrateDrug
Also called Ferotab
Clomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Letrozole Receives: Drug: Letrozole |
| 2 | Active comparator | Clomiphene citrate Receives: Drug: Clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
Measured: 3 cycles
Secondary outcomes (2)
Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
Measured: 3 cycles
Safety
Measured: 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startDec 2004
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mandakini Parihar, M.D., D.G.O., Principal investigator, Director, IVF Centre, Chembur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610077
- Sponsor's protocol ID
- LET/SPIL/03/06
- Status last verified
- Jan 2008
- First submitted
- 24 Jan 2008
- Last updated
- 7 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized, Parallel-Group, Multicentric, Comparative Study of Letrozole With Clomiphene Citrate for Induction of Ovulation in Anovulatory Infertility.
- ClinicalTrials.gov ID
- NCT00610077
- Acronym / sponsor ID
- LET/SPIL/03/06
- Conditions
- Infertility
- Keywords
- Letrozole, Clomiphene citrate, Anovulatory infertility, Ovulation induction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.
Detailed description
MAIN OUTCOME MEASURE(S): Occurrence of ovulation, endometrial thickness and pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LetrozoleLetrozole |
| 2 | Active comparator | Drug: Clomiphene citrateClomiphene citrate |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Females with anovulatory infertility 20-38 years of age.
- Diagnosis of anovulatory infertility as established by standard criteria.
- Normal Pelvic USG and bilateral tubal patency
- Willingness and giving written Informed Consent.
Key exclusion criteria (15 listed)
- Uterine and adnexal pathology e.g. leiomyomata
- Ovarian cyst
- Hyperprolactinaemia
- Hyperthyroidism or Hypothyroidism*
- FSH >9mIU/ml (during early follicular phase).* (As per Chemoluminescence method)
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 |
|---|---|---|
| LetrozoleAlso: LetrozTablet Letrozole 2.5 mg once a day for 5 days for 3 cycles | Drug | 1 |
| Clomiphene citrateAlso: FerotabClomiphene citrate 100 mg or 150 mg once a day for 5 days in 3 cycles | Drug | 2 |
Primary outcome
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).
Time frame: 3 cycles
2 secondary outcomes
Pregnancy Rate (Detection of pregnancy by beta-hCG and Ultrasonography) b. Endometrial thickness by Ultrasonography.
Time frame: 3 cycles
Safety
Time frame: 3 cycles
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2008.
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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.
Mandakini Parihar, M.D., D.G.O. principal investigator
Director, IVF Centre, Chembur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole and Clomiphene citrate in people with Infertility, run by Sun Pharmaceutical Industries Limited at 1 site in India.
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 4 inclusion and 15 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: finished, as of the sponsor's last update on 7 Feb 2008. 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 India. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG). (time frame: 3 cycles). 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 7 Feb 2008.