Ovarian ReservePhase 4NCT03789123
Effects of Dienogest and Dienogest Plus Estradiol Valerate in Ovarian Endometrioma
A Phase 4 study testing Estradiol valerate/dienogest in people with Ovarian Reserve, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Reserve
- What is being tested?
- Estradiol valerate/dienogest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 710 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Dec 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom
- Control Group: Patients with reproductive age without any ovarian cysts
Who cannot join
- suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tolga Karacan
Istanbul, Bagcilar, 34100
Tolga Karacan, M.D, 5303638765, tolgakaracan84@gmail.com
Gulfem Basol, M.D
About this study
Official title: Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size
Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.
- Conditions
- Ovarian Reserve
- Being tested
- Estradiol valerate/dienogest
- Keywords
- Endometrioma, Estradiol valerate + dienogest, Dienogest, Ovarian reserve
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol valerate/dienogestDrug
Also called Dienogest
The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
| Study group | Role | What they receive |
|---|---|---|
| Study Group (patients with OMA) | Experimental | I) Untreated patients (n=142)
II) Dienogest (n=142)
III) Dienogest/Estradiol valerate+Dienogest (n=142) Receives: Drug: Estradiol valerate/dienogest |
| Control Group(patients without OMA) | Sham comparator | I) Untreated patients (n=142)
II) Dienogest/Estradiol valerate+Dienogest (n=142) Receives: Drug: Estradiol valerate/dienogest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve
The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.
Measured: up to 24 months
Secondary outcomes (2)
Endometrioma Size
The investigators evaluate endometrioma size (centimeter) using ultrasonography.
Measured: up to 24 months
Pain Score
Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ReserveStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Kocaeli Derince Education and Research Hospital, Suleymaniye Birth And Women's Health Education And Research Hospital
- Responsible party
- Sponsor
- Investigators
- Engin Oral, Prof.Dr. M.D, Study director, Istanbul University Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789123
- Sponsor's protocol ID
- 2018.11.1.01.082.r1.101
- Status last verified
- Dec 2018
- First submitted
- 22 Nov 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size
- ClinicalTrials.gov ID
- NCT03789123
- Acronym / sponsor ID
- 2018.11.1.01.082.r1.101
- Conditions
- Ovarian Reserve
- Keywords
- Endometrioma, Estradiol valerate + dienogest, Dienogest, Ovarian reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Collaborators
- Kocaeli Derince Education and Research Hospital, Suleymaniye Birth And Women's Health Education And Research Hospital
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 28 Dec 2018 (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.
Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (patients with OMA) | Experimental | Drug: Estradiol valerate/dienogestI) Untreated patients (n=142) II) Dienogest (n=142) III) Dienogest/Estradiol valerate+Dienogest (n=142) |
| Control Group(patients without OMA) | Sham comparator | Drug: Estradiol valerate/dienogestI) Untreated patients (n=142) II) Dienogest/Estradiol valerate+Dienogest (n=142) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Study Group: At least one endometrioma greater than 3 cm, between 18-40 years of age, without surgical indication at the time of diagnosis, occasionally and intermittently controlled pain with NSAIDs or no pain symptom
- Control Group: Patients with reproductive age without any ovarian cysts
Key exclusion criteria (1 listed)
- suspicion of malignancy, irregular mentrual period, endocrine diseases, drug intake that may affect ovarian reserve in the last 6 months (i.e GnRH agonists), previous ovarian surgery, AMH levels under 2 ng/ml.
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 |
|---|---|---|
| Estradiol valerate/dienogestAlso: DienogestThe effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score. | Drug | Control Group(patients without OMA), Study Group (patients with OMA) |
Primary outcome
Ovarian reserve
Time frame: up to 24 months
The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome.
2 secondary outcomes
Endometrioma Size
Time frame: up to 24 months
Pain Score
Time frame: up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Ovarian Reserve
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Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
Premature Ovarian Insufficiency, POI
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Oral GDC-0077 in Premature Ovarian Insufficiency
Primary Ovarian Insufficiency
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Study of Ovarian Reserve Concerning Patients With Multiple Sclerosis (MS), Compared to a Control Group
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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.
Engin Oral, Prof.Dr. M.D study director
Istanbul University Cerrahpasa Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Estradiol valerate/dienogest in people with Ovarian Reserve, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 28 Dec 2018. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tolga Karacan, M.D (05303638765, tolgakaracan84@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian reserve (time frame: up to 24 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 28 Dec 2018.