Adverse Effects of Medical DrugsPhase 4NCT02855138
Effects of Isotretinoin on The Gonads and Hirsutism
A Phase 4 study testing oral isotretinoin in people with Adverse Effects of Medical Drugs, run by Kayseri Education and Research Hospital.
Trial summary
The investigators consider that there are some rising concerns about the use of isotretinoin by women of reproductive age with depleted ovarian reserve, hence it is important to detect the effect of isotretinoin on ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Adverse Effects of Medical Drugs
- What is being tested?
- oral isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended our obstetrics and gynecology clinic for the treatment menstrual irregularities and hirsutism
Who cannot join
- 1)presence of any dermatologic disorder besides acne 2) presence of any systemic disease 3) exposure to any systemic treatment in the last three months that could alter ovarian reserve 4) pregnancy or lactation 5) infection diseases 6) use of antidepressants, steroidal hormone drugs, mood stabilizers, caffeine, alcohol, or tobacco 7) histories of abdominal surgery for endometriosis or ovarian surgery
About this study
Official title: The Effects of Oral Isotretinoin in Women With Acne and Polycystic Ovary Syndrome
The investigators consider that there are some rising concerns about the use of isotretinoin by women of reproductive age with depleted ovarian reserve, hence it is important to detect the effect of isotretinoin on ovarian reserve.
There has not been a well-designed study evaluating its effects on the human ovarian reserve, hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this reasons, this study was administered to determine whether there is an effect of isotretinoin on the gonads and hirsutism in women with acne and PCOS.
- Conditions
- Adverse Effects of Medical Drugs
- Being tested
- oral isotretinoin
- Keywords
- isotretinoin, PCOS, acne vulgaris
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral isotretinoinDrug
Also called roaccutane
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | The study group consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended the obstetrics and gynecology clinic for the treatment of menstrual irregularities and hirsutism.The patients were treated with 0.6-0.8 mg/kg oral isotretinoin up to a total dose of 120-150 mg/kg. Treatment was started at 20 mg/day and gradually increased to the maximum of 40 mg/day. The patients were monitored monthly during isotretinoin treatment. Receives: Drug: oral isotretinoin |
| control group | No intervention | The control group of this study was pretreatment period of the same volunteer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events on the Gonads and Hirsutism That are Related to Treatment
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adverse Effects of Medical DrugsStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Kayseri Erciyes University Faculty of Medicine
- Responsible party
- Principal investigator, Gökhan Açmaz, Kayseri Education and Research Hospital
- Investigators
- GÖKHAN ACMAZ, Principal investigator, Kayseri Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855138
- Sponsor's protocol ID
- 2016/358
- Status last verified
- Jul 2016
- First submitted
- 1 Aug 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
Publications
Acmaz G, Cinar L, Acmaz B, Aksoy H, Kafadar YT, Madendag Y, Ozdemir F, Sahin E, Muderris I. The Effects of Oral Isotretinoin in Women with Acne and Polycystic Ovary Syndrome. Biomed Res Int. 2019 Apr 7;2019:2513067. doi: 10.1155/2019/2513067. eCollection 2019.
PubMed 31080813
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Isotretinoin in Women With Acne and Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02855138
- Acronym / sponsor ID
- 2016/358
- Conditions
- Adverse Effects of Medical Drugs
- Keywords
- isotretinoin, PCOS, acne vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kayseri Education and Research HospitalOther government
- Collaborators
- Kayseri Erciyes University Faculty of Medicine
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Aug 2016 (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.
The investigators consider that there are some rising concerns about the use of isotretinoin by women of reproductive age with depleted ovarian reserve, hence it is important to detect the effect of isotretinoin on ovarian reserve.
There has not been a well-designed study evaluating its effects on the human ovarian reserve, hormone levels and menstrual cycles in women with polycystic ovary syndrome (PCOS). For this reasons, this study was administered to determine whether there is an effect of isotretinoin on the gonads and hirsutism in women with acne and PCOS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: oral isotretinoinThe study group consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended the obstetrics and gynecology clinic for the treatment of menstrual irregularities and hirsutism.The patients were treated with 0.6-0.8 mg/kg oral isotretinoin up to a total dose of 120-150 mg/kg. Treatment was started at 20 mg/day and gradually increased to the maximum of 40 mg/day. The patients were monitored monthly during isotretinoin treatment. |
| control group | No intervention | –The control group of this study was pretreatment period of the same volunteer patients. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- consisted of 40 volunteers women with PCOS (aged 18- 40 years, BMI, 18-44kg/m2) who attended our obstetrics and gynecology clinic for the treatment menstrual irregularities and hirsutism
Key exclusion criteria (1 listed)
- 1)presence of any dermatologic disorder besides acne 2) presence of any systemic disease 3) exposure to any systemic treatment in the last three months that could alter ovarian reserve 4) pregnancy or lactation 5) infection diseases 6) use of antidepressants, steroidal hormone drugs, mood stabilizers, caffeine, alcohol, or tobacco 7) histories of abdominal surgery for endometriosis or ovarian surgery
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 isotretinoinAlso: roaccutane | Drug | study group |
Primary outcome
Adverse Events on the Gonads and Hirsutism That are Related to Treatment
Time frame: six months
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 5 Aug 2016.
- Derived from this study: PubMed 31080813Acmaz G, Cinar L, Acmaz B, Aksoy H, Kafadar YT, Madendag Y, Ozdemir F, Sahin E, Muderris I. The Effects of Oral Isotretinoin in Women with Acne and Polycystic Ovary Syndrome. Biomed Res Int. 2019 Apr 7;2019:2513067. doi: 10.1155/2019/2513067. eCollection 2019.
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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.
GÖKHAN ACMAZ principal investigator
Kayseri Education and Research Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral isotretinoin in people with Adverse Effects of Medical Drugs, run by Kayseri Education and Research Hospital.
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 1 inclusion and 1 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Adverse Events on the Gonads and Hirsutism That are Related to Treatment (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855138, which also lists 1 linked publication.
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 5 Aug 2016.