InfertilityPhase 3NCT03134157
The Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Women
A Phase 3 study of Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Aug 2016to 14 Sep 2021
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 20-40 years
- Intramural Fibroids confirmed by ultrasound
- Presence of at least one fibroid with size >4 cm or two fibroids with size >3 cm detected by pelvic ultrasound.
- Presence of at least 3 fibroids with size <3 cm and a history of 2 IVF failures.
- Number of fibroids ≤ 5
- BMI>25 Kg/m2
Who cannot join
- Pregnancy
- Hormonal contraception or any hormonal therapy received in the last 3 months
- Alcohol consumption
- Allergic to simvastatin
- Suspicion or diagnosis of cancer
- Signs or symptoms of mental illness, hepatic dysfunction, myopathic syndromes, diabetes mellitus, renal disease, Cardiovascular disease, hypothyroidism, hypotension, neuropathy, lupus and cataract
Show all 11Show fewer
- Hb ≤ 7
- Taking antifungal medications, Lipid-Lowering medications (gemfibrozil, clofibrate), warfarin, danazol and erythromycin in the last one month.
- Severe male factor
- Severe endometriosis
- Diminished ovarian reserve
Trial locations and contacts
1 site in 1 country.
Leila Arab, MD contact
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehrān
Nasser Aghdami, MD,PhD, (+98)2123562000 ext. 516, nasser.aghdami@royaninstitute.org
Leila Arab, MD, (+98)2123562000 ext. 414, Leara91@gmail.com
About this study
Official title: Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients
Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.
Read the detailed description
The proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.
CBC, Lipid profile, kidney \& Liver function tests, FBS \& hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus.
- Conditions
- Infertility
- Being tested
- oral drug and vaginal placebo, oral drug and oral placebo, Vaginal placebo+ oral placebo
- Keywords
- Leiomyoma simvastatin infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral drug and vaginal placeboDrug
prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.
oral drug and oral placeboDrug
prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.
Vaginal placebo+ oral placeboDrug
prescription of Vaginal placebo + oral placebo every day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin and vaginal placebo | Experimental | The patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months. Receives: Drug: oral drug and vaginal placebo |
| Simvastatin and oral placebo | Experimental | The patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months. Receives: Drug: oral drug and oral placebo |
| Vaginal placebo+ oral placebo | Experimental | The patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months. Receives: Drug: Vaginal placebo+ oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine fibroid size
Evaluation the size of Uterine fibroid withultrasound.
Measured: 3 months
Secondary outcomes (2)
Uterine size
Evaluation the uterine size with ultrasound.
Measured: 3months
Plasma concentration of Vitamin D3
Evaluation the Plasma concentration of Vitamin D3 with blood sampling.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study startAug 2016
- Primary completion14 Jun 2021 (estimated)
- Study completion14 Sep 2021 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mahnaz Ashrafi, MD, Study director, ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, IranHamid Gourabi, PhD, Study chair, Head of Royan InstituteFiroozeh Ahmadi, MD, Study director, ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, IranNadia Jahangiri, MSc, Principal investigator, ) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134157
- Sponsor's protocol ID
- Royan-Emb-029
- Status last verified
- Oct 2020
- First submitted
- 26 Apr 2017
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Simvastatin on Uterine Leiomyoma Development and Growth in Infertile Patients
- ClinicalTrials.gov ID
- NCT03134157
- Acronym / sponsor ID
- Royan-Emb-029
- Conditions
- Infertility
- Keywords
- Leiomyoma simvastatin infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Aug 2016 (actual)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 14 Sep 2021 (estimated)
- First posted
- 28 Apr 2017 (actual)
- 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.
Uterine leiomyomas with an estimated incidence of 50%-80% are the most common tumors of female reproductive system. Statins as a HMG-CoA reductase inhibitors inhibit the mevalonate pathway of cholesterol synthesis, thus have been known as a group of drugs used for treatment of hypercholesterolemia. Statins inhibit proliferation of several cell types including vascular smooth muscle, hepatocytes and other cell types. Leiomyomas are benign uterine tumors characterized by smooth muscle proliferation and excessive deposition of extracellular matrix. In the present study we aim to evaluate the effect of simvastatin on uterine leiomyoma development and growth.
Detailed description
The proposal of the present study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into three groups and will be randomized to receive simvastatin 40 mg orally + vaginal placebo, simvastatin 40 mg vaginally + oral placebo and vaginal placebo + oral placebo for 3 months.
CBC, Lipid profile, kidney \& Liver function tests, FBS \& hormonal evaluation will be performed before and after the treatment. Ultrasound examination will be performed before and after the treatment for determining of the number, size, and site of the myoma and also size of the uterus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simvastatin and vaginal placebo | Experimental | Drug: oral drug and vaginal placeboThe patients with leiomyoma receive simvastatin 40 mg orally+ vaginal placebo will be given every day for 3 months. |
| Simvastatin and oral placebo | Experimental | Drug: oral drug and oral placeboThe patients with leiomyoma receive simvastatin 40 mg orally+ oral placebo will be given every day for 3 months. |
| Vaginal placebo+ oral placebo | Experimental | Drug: Vaginal placebo+ oral placeboThe patients with leiomyoma receive Vaginal placebo+ oral placebo every day for 3 months. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 20-40 years
- Intramural Fibroids confirmed by ultrasound
- Presence of at least one fibroid with size >4 cm or two fibroids with size >3 cm detected by pelvic ultrasound.
- Presence of at least 3 fibroids with size <3 cm and a history of 2 IVF failures.
- Number of fibroids ≤ 5
Key exclusion criteria (11 listed)
- Pregnancy
- Hormonal contraception or any hormonal therapy received in the last 3 months
- Alcohol consumption
- Allergic to simvastatin
- Suspicion or diagnosis of cancer
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 |
|---|---|---|
| oral drug and vaginal placeboprescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months. | Drug | Simvastatin and vaginal placebo |
| oral drug and oral placeboprescription of simvastatin 40 mg orally+ oral placebo every day for 3 months. | Drug | Simvastatin and oral placebo |
| Vaginal placebo+ oral placeboprescription of Vaginal placebo + oral placebo every day for 3 months. | Drug | Vaginal placebo+ oral placebo |
Primary outcome
Uterine fibroid size
Time frame: 3 months
Evaluation the size of Uterine fibroid withultrasound.
2 secondary outcomes
Uterine size
Time frame: 3months
Plasma concentration of Vitamin D3
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Leila Arab, MD contact
Mahnaz Ashrafi, MD study director
) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Hamid Gourabi, PhD study chair
Head of Royan Institute
Firoozeh Ahmadi, MD study director
) Endocrinology and Female Infertility Department, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
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 of Infertility, run by Royan Institute at 1 site in Iran.
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: status not confirmed, as of the sponsor's last update on 6 Oct 2020. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD ((+98)23562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine fibroid size (time frame: 3 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 6 Oct 2020.