Female Reproductive ProblemPhase 2NCT02644304
Clomiphene Citrate Plus Cabergoline in Treatment of Polycystic Ovary Syndrome
A Phase 2 study testing Clomiphene citrate and Cabergoline in people with Female Reproductive Problem, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged women and affects approximately 5-12 % of the female population. In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected individuals must have two out of the following three criteria: 1. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Female Reproductive Problem
- What is being tested?
- Clomiphene citrate and Cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 2
- 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
- 2 or more of PCOS signs according to Rotterdam diagnostic criteria (2003).-
- Primary or secondary infertility.-
- Absence of galactorrhoea
- Normal serum prolactin or slightly elevated (up to 50 ng/dl)
- Normal hysterosalpingography
- Normal spermogram
Who cannot join
- Women on other line of treatment as aromatase inhibitors, gonadotrophins, or tamoxifen.
- Known hypersensitivity for Clomiphene citrate or cabergoline.
- Other factors of infertility as tubal factor, uterine factor or male factor.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university
Asyut, 71111
Kamal M Zahran, MD
About this study
Official title: Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged women and affects approximately 5-12 % of the female population.
In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected individuals must have two out of the following three criteria:
Read more
- Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).
- Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank virilization, while chemical indicators include raised concentrations of total testosterone and androstenedione , and elevated free androgen index.
- Polycystic ovaries on sonographic examination, presence of 12 or more follicles in either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3 and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic criteria, the majority of women with PCOS can be diagnosed without the need of laboratory examinations.
Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation. It is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the latter being the more potent of the two. It is a non-steroidal compound closely resembling estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby signaling a lack of circulating estrogens and inducing a change in the pulsatile release of gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone from the anterior pituitary and is often enough to set the cycle of events leading to ovulation into motion.
Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg, which could be increased, if needed, to twice a week. This medicine has slight dopamine agonistic side effects, headache being the most common one. Treatment in the very beginning should start with a partial dose (half a pill) at bedtime with a small amount of food. Low incidence of side effects and its weekly dose has made Cabergoline a choice drug for treatment of related diseases.
- Conditions
- Female Reproductive Problem
- Being tested
- Clomiphene citrate, Cabergoline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomiphene citrateDrug
50 mg tablet twice daily from the second day of menses to the sixth day
CabergolineDrug
Cabergoline 0.25 mg (half tablet) every 3 days (4 doses).
PlaceboOther
placebo(half tablet) every 3 days (4 doses).
| Study group | Role | What they receive |
|---|---|---|
| Clomiphene citrate plus cabergoline | Active comparator | This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus cabergoline 0.25 mg from second day every 3 days (4 doses only) Receives: Drug: Clomiphene citrate; Drug: Cabergoline |
| Clomiphene citrate plus placebo | Active comparator | This group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus placebo tablets from second day every 3 days (4 doses only) Receives: Drug: Clomiphene citrate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of mature follicles (mm).
Measured: 1 year
Secondary outcomes (2)
Number of pregnancy
Measured: 1 year
Number of mature follicles (mm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Reproductive ProblemStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Mohamed Zahran, Woman's Health University Hospital, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644304
- Sponsor's protocol ID
- CC in PCOS
- Status last verified
- Jun 2016
- First submitted
- 13 Oct 2015
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clomiphene Citrate Plus Cabergoline Versus Clomiphene Citrate Alone in Treatment of Polycystic Ovary Syndrome Associated Infertility
- ClinicalTrials.gov ID
- NCT02644304
- Acronym / sponsor ID
- CC in PCOS
- Conditions
- Female Reproductive Problem
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Dec 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.
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of reproductive aged women and affects approximately 5-12 % of the female population.
In 2003 in Rotterdam , Rotterdam diagnostic criteria were redefined PCOS as affected individuals must have two out of the following three criteria:
- Oligo- and/or anovulation, (ovulation occurs less than once every 35 days).
- Hyperandrogenism, clinical signs include hirsutism, acne, alopecia, and frank virilization, while chemical indicators include raised concentrations of total testosterone and androstenedione , and elevated free androgen index.
- Polycystic ovaries on sonographic examination, presence of 12 or more follicles in either ovary measuring 2-9 mm in diameter, increased ovarian volume more than 10 cm3 and/or increase in stromal echogenicity. Clearly, according to the Rotterdam diagnostic criteria, the majority of women with PCOS can be diagnosed without the need of laboratory examinations.
Clomiphene citrate (CC) is still the first-line medication for the induction of ovulation. It is an anti-estrogenic compound made up of two isomers, enclomiphene and zuclomiphene; the latter being the more potent of the two. It is a non-steroidal compound closely resembling estrogen. CC acts by blocking estrogen receptors, particularly in the hypothalamus, thereby signaling a lack of circulating estrogens and inducing a change in the pulsatile release of gonadotrophin-releasing hormone (GnRH). This induces release of follicle stimulating hormone from the anterior pituitary and is often enough to set the cycle of events leading to ovulation into motion.
Cabergoline, ergot-derived dopamine agonists with a very long half life, is an effective prolactin suppressor. Cabergoline oral administration contains a weekly dose of 0.5 - 3 mg, which could be increased, if needed, to twice a week. This medicine has slight dopamine agonistic side effects, headache being the most common one. Treatment in the very beginning should start with a partial dose (half a pill) at bedtime with a small amount of food. Low incidence of side effects and its weekly dose has made Cabergoline a choice drug for treatment of related diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clomiphene citrate plus cabergoline | Active comparator | Drug: Clomiphene citrate, Drug: CabergolineThis group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus cabergoline 0.25 mg from second day every 3 days (4 doses only) |
| Clomiphene citrate plus placebo | Active comparator | Drug: Clomiphene citrate, Other: PlaceboThis group will receive Clomiphene citrate 50 mg tablet twice daily from the second day of menses to the sixth day plus placebo tablets from second day every 3 days (4 doses only) |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 2 or more of PCOS signs according to Rotterdam diagnostic criteria (2003).-
- Primary or secondary infertility.-
- Absence of galactorrhoea
- Normal serum prolactin or slightly elevated (up to 50 ng/dl)
- Normal hysterosalpingography
Key exclusion criteria (3 listed)
- Women on other line of treatment as aromatase inhibitors, gonadotrophins, or tamoxifen.
- Known hypersensitivity for Clomiphene citrate or cabergoline.
- Other factors of infertility as tubal factor, uterine factor or male factor.
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 |
|---|---|---|
| Clomiphene citrate50 mg tablet twice daily from the second day of menses to the sixth day | Drug | Clomiphene citrate plus cabergoline, Clomiphene citrate plus placebo |
| CabergolineCabergoline 0.25 mg (half tablet) every 3 days (4 doses). | Drug | Clomiphene citrate plus cabergoline |
| Placeboplacebo(half tablet) every 3 days (4 doses). | Other | Clomiphene citrate plus placebo |
Primary outcome
Size of mature follicles (mm).
Time frame: 1 year
2 secondary outcomes
Number of pregnancy
Time frame: 1 year
Number of mature follicles (mm)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clomiphene citrate and Cabergoline in people with Female Reproductive Problem, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
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 3 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 29 Jun 2016. 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 Egypt. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Kamal M Zahran, MD (+20882414616, drzahranmk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of mature follicles (mm). (time frame: 1 year). 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 29 Jun 2016.