Polycystic OvariesPhase 4PCOSNCT02352597
Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS
A Phase 4 study testing phytoestrogen, estradiol valerate and clomiphene citrate in people with Polycystic Ovaries, run by Cairo University.
Trial summary
Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11… Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Polycystic Ovaries
- What is being tested?
- phytoestrogen, estradiol valerate and clomiphene citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2015
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.
Who cannot join
- women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study
About this study
Official title: Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome
Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.
Read the detailed description
Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.
- Conditions
- Polycystic Ovaries
- Being tested
- phytoestrogen, estradiol valerate, clomiphene citrate
- Keywords
- PCOS, Phytoestrogens, ovulation induction
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phytoestrogenDrug
Also called Klimadynon
20mg of cimifuga racemosa from day 1- 12
estradiol valerateDrug
Also called cycloprogynova
2mg from cycle day 7 to day 11
clomiphene citrateDrug
Also called clomid
50 mg orally every 8 hours started from cycle day 3 for 5 days
| Study group | Role | What they receive |
|---|---|---|
| clomiphene citrate | Active comparator | only50 mg orally every 8 hours started from cycle day 3 for 5 days Receives: Drug: clomiphene citrate |
| estradiol valerate and CC | Active comparator | 2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC Receives: Drug: estradiol valerate; Drug: clomiphene citrate |
| Phytoestrogen and CC | Active comparator | 20mg of cimifuga racemosaorally from day 1- 12) in addition to CC Receives: Drug: phytoestrogen; Drug: clomiphene citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrial thickness
Measured: day 14 of menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic OvariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352597
- Sponsor's protocol ID
- 222
- Acronym
- PCOS
- Status last verified
- Mar 2017
- First submitted
- 25 Jan 2015
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT02352597
- Acronym / sponsor ID
- PCOS / 222
- Conditions
- Polycystic Ovaries
- Keywords
- PCOS, Phytoestrogens, ovulation induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Feb 2015 (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.
Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.
Detailed description
Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| clomiphene citrate | Active comparator | Drug: clomiphene citrateonly50 mg orally every 8 hours started from cycle day 3 for 5 days |
| estradiol valerate and CC | Active comparator | Drug: estradiol valerate, Drug: clomiphene citrate2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC |
| Phytoestrogen and CC | Active comparator | Drug: phytoestrogen, Drug: clomiphene citrate20mg of cimifuga racemosaorally from day 1- 12) in addition to CC |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.
Key exclusion criteria (1 listed)
- women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study
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 |
|---|---|---|
| phytoestrogenAlso: Klimadynon20mg of cimifuga racemosa from day 1- 12 | Drug | Phytoestrogen and CC |
| estradiol valerateAlso: cycloprogynova2mg from cycle day 7 to day 11 | Drug | estradiol valerate and CC |
| clomiphene citrateAlso: clomid50 mg orally every 8 hours started from cycle day 3 for 5 days | Drug | Phytoestrogen and CC, clomiphene citrate, estradiol valerate and CC |
Primary outcome
endometrial thickness
Time frame: day 14 of menstrual cycle
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 24 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovaries
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phytoestrogen, estradiol valerate and clomiphene citrate in people with Polycystic Ovaries, run by Cairo University.
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 24 Mar 2017. 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?
endometrial thickness (time frame: day 14 of menstrual cycle). 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 24 Mar 2017.