A Survey on Efficacy and Safety in Patients With Endometriosis

An observational study of Endometriosis, run by Mylan Inc. at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients with endometriosis under actual condition of its use and to obtain data for effectively and safely utilizing this drug. Read more about this study

Who is it for?: Ages 20 to 49 years, women only
Conditions the study is for: Endometriosis
What is being tested?: Dydrogesterone
Type of treatment: Pill or oral medicine
How many people: 60 participants
Where: 15 sitesJapan
Study dates: 23 Aug 2016to 13 Oct 2017
How long will I take part?: 7 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 49 years
Women only
No healthy volunteers
Adult

Study population: The subjects of the survey will be patients with a diagnosis of endometriosis.

Who may be able to join

Women aged 20 to < 50 years
Subjects with a chocolate cyst of the ovary measuring 3 cm in diameter on transvaginal ultrasonography at patient enrollment
Subjects with a menstrual cycle of 25 to 38 days who ovulate and are confirmed to have normal menstruation at patient enrollment

Who cannot join

Subjects who used GnRH agonists within 6 months before patient enrollment
Subjects who utilized hormone preparations containing corpus luteum hormone or estrogen as an active ingredient, low-dose contraceptive pills, middle-dose contraceptive pills, testosterone derivatives, or herbal products indicated for endometriosis within 3 months before patient enrollment
Subjects who received surgical treatment for endometriosis such as transvaginal alcohol fixation, laparotomy or laparoscopic surgery within 2 months before patient enrollment
Subjects who are pregnant or may possibly be pregnant at patient enrollment
Subjects who are in breast feeding at patient enrollment
Subjects who are determined by the investigator/subinvestigator to be not suitable for the subjects of the survey because of other reasons

Show all 15Show fewer

Subjects with liver disorder or liver disease
Subjects with known hypersensitivity to the active substance or to any of the excipients
Subjects with known or suspected progestogen dependent neoplasms (e.g. meningioma)
Subjects with undiagnosed vaginal bleeding
Subjects with a past or current history of heart or kidney disease
Subjects with porphyria
Subjects with depression
Subjects with abnormal liver function values caused by acute or chronic liver disease
Subjects with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Japan15 sites

Mylan Investigational Site B
Bunkyō, Tokyo, 113-8655
Mylan Investigational Site A
Kamigyō-ku, Kyoto, 602-8566
Mylan Investigational Site C
Kyoto, Fushimiku, 612-0064
Mylan Investigational Site H
Kyoto, Kyotanabeshi, 610-0357
Mylan Investigational Site I
Kyoto, Nakagyoku, 604-0965
Mylan Investigational Site K
Kyoto, Nakagyoku, 604-8381
Mylan Investigational Site F
Kyoto, Nakagyoku, 604-8453
Mylan Investigational Site E
Kyoto, Ukyouku, 615-0883
Mylan Investigational Site L
Kyoto, Yosanocho, 629-2261
Mylan Investigational Site M
Okayama, Kurashikishi, 710-0824
Mylan Investigational Site D
Saitama, Iwatsukiku, 339-0057
Mylan Investigational Site O
Tokushima, 770-8503
Mylan Investigational Site G
Tokyo, Chiyodaku, 101-0062
Mylan Investigational Site N
Tokyo, Chuouku, 104-8560
Mylan Investigational Site J
Tokyo, Shibuyaku, 151-0051

Other trials in Japan

About this study

Official title: Duphaston® Tablets 5 mg - A Survey on Efficacy and Safety in Patients With Endometriosis

Read the detailed description

In Japan, Duphaston® Tablets have appeared in 1965 for the treatment of endometriosis and been used at some medical institutions. However, after releasing of danazol in the early 1980's and gonadotropin-releasing hormone (GnRH) agonists in the late 1980's, pseudomenopause therapy became mainstream because of its high efficacy. However, pseudopregnancy therapy was recognized again due to adverse reactions associated with pseudomenopause therapy. After 2000, low-dose estrogen/progestin (LEP) combination drugs (as LEP products, ethinylestradiol/norethisterone combination drug and ethinylestradiol/drospirenone combination drug) and dienogest have been utilized as drugs that are safer and can be administered for a long time. In recent years, Duphaston® Tablets are increasing recognized again from the viewpoints of its efficacy and safety because the drug has no effect to inhibit ovulation or effect on basal body temperature, a diagnosis of ovulation and other conditions may be made by following up basal body temperature, and pregnancy may be achieved even during treatment with Duphaston. As previously mentioned, Duphaston® Tablets are an old drug, and there are only few clinical data from Japanese patients; thus, its latest clinical efficacy and safety data are being demanded again mainly by obstetrician-gynecologists.

Conditions: Endometriosis
Being tested: Dydrogesterone
Medical subject headings: Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DydrogesteroneDrug
Also called Duphaston

Study groups in NCT02921763
Study group	Role	What they receive
Dydrogesterone		Dydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4. Receives: Drug: Dydrogesterone

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume)
In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: [(D1 + D2) × 1/2]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner.
The change rate within ±15% from the total volume measured before treatment was defined as "unchanged," and the rate out of this range was defined as "decreased" or "increased."
Measured: Before treatment initiation (baseline), 3 months, and 5 months.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume)
In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: [(D1 + D2) × 1/2]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner.
Measured: Before treatment initiation (baseline), 3 months, and 5 months.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline
The absolute change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
For the mean value of the absolute changes shown here, the mean value of the absolute changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the absolute change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the absolute change in 40 cases with the volume value at this time.
The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the absolute change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5.
For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.
Measured: Before treatment initiation (baseline), 3 months, and 5 months.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline
The % change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
For the mean value of the % changes shown here, the mean value of the % changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the % change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the % change in 40 cases with the volume value at this time.
The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the % change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5.
For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.
Measured: Before treatment initiation (baseline), 3 months, and 5 months.

Secondary outcomes (8)

Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score)
The dysmenorrhea score is the sum of the dysmenorrhea severity score and the analgesic use score. Shown as the mean value for the number of cases at each time point.
A dysmenorrhea severity score is defined as follows. None: Score 0, Rarely interfering with work (study and house work): Score 1, Interfering with work (study and house work) requiring lying down to rest: Score 2, Being confined to bed for 1 day, being unable to work (study and house work): Score 3.
A analgesic use score is defined as follows. None: Score 0, An analgesic was used for a day during the last (or current) menstruation period: Score 1, An analgesic was used for 2 days during the last (or current) menstruation period: Score 2, An analgesic was used for 3 days during the last (or current) menstruation period: Score 3 The minimum dysmenorrhea score is 0 and the maximum dysmenorrhea score is 6.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea
A straight line with a total length of 10 cm was prepared. This straight line was defined as "no pain" at the left end and "Worst pain imaginable" at the right end.
The cases marked the degree of pain on this straight line at each time point, and the length (cm) from the left end of the line (0) was measured.
The minimum value of VAS is 0 cm (no pain) and the maximum value is 10 cm (Worst pain imaginable).
The units on a scale is "cm".
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change in Serum CA125
CA-125 is a glycoprotein antigen recognized by the monoclonal antibody OC125 made against ovarian cancer cell cultures.
Serum CA125 is commonly used as a tumor marker for ovarian cancer, and since it increases at a high rate in endometriosis, it has an aspect of being used as a diagnostic aid for endometriosis.
There are many reports that the normal value of serum CA-125 is 35 U/mL or less.
The test was performed during a non-menstruation period, as serum CA-125 levels are high during the menstrual period.
Measured: Baseline, and 5 months.
Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score), Difference From Baseline
The dysmenorrhea score is the sum of the dysmenorrhea severity score and the analgesic use score.
The difference from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
A dysmenorrhea severity score is defined as follows. None: Score 0, Rarely interfering with work (study and house work): Score 1, Interfering with work (study and house work) requiring lying down to rest: Score 2, Being confined to bed for 1 day, being unable to work (study and house work): Score 3.
A score for the use of analgesics is defined as follows. None: Score 0, An analgesic was used for a day during the last (or current) menstruation period: Score 1, An analgesic was used for 2 days during the last (or current) menstruation period: Score 2, An analgesic was used for 3 days during the last (or current) menstruation period: Score 3
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Difference From Baseline
A straight line with a total length of 10 cm was prepared. This straight line was defined as "no pain" at the left end and "Worst pain imaginable" at the right end.
The cases marked the degree of pain on this straight line at each time point, and the length (cm) from the left end of the line (0) was measured.
The minimum value of VAS is 0 cm (no pain) and the maximum value is 10 cm (Worst pain imaginable).
The units on a scale is "cm". The difference from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Change Rate From Baseline (%)
A straight line with a total length of 10 cm was prepared. This straight line was defined as "no pain" at the left end and "Worst pain imaginable" at the right end.
The cases marked the degree of pain on this straight line at each time point, and the length (cm) from the left end of the line (0) was measured.
The minimum value of VAS is 0 cm (no pain) and the maximum value is 10 cm (Worst pain imaginable).
The change rate from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
Measured: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change in Serum CA125, Difference From Baseline
The difference from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
For the mean value of the difference shown here, the mean value of the difference of the cases that could be measured at each time point is calculated.
In other words, of the 56 cases with baseline serum CA125, cycle 5 can only calculate the difference in 32 cases with serum CA125 at this point.
The mean difference between cycle 5 and baseline in these 32 cases is shown here.
The remaining 24 cases in Baseline are excluded from this calculation because they do not have serum CA125 measurements in Cycle 5.
For this reason, these values cannot be calculated directly from the serum CA125 mean value at each time point shown in the result measurement 7.
Measured: Baseline, and 5 months.
Change in Serum CA125, Change Rate From Baseline (%)
The change rate from baseline were calculated on an individual basis and these were totalled and means ± SD calculated.
For the mean value of the change rate shown here, the mean value of the change rate of the cases that could be measured at each time point is calculated.
In other words, of the 56 cases with baseline serum CA125, cycle 5 can only calculate the change rate in 32 cases with serum CA125 at this point.
The mean change rate between cycle 5 and baseline in these 32 cases is shown here.
The remaining 24 cases in baseline are excluded from this calculation because they do not have serum CA125 measurements in Cycle 5.
For this reason, these values cannot be calculated directly from the serum CA125 mean value at each time point shown in the result measurement 7.
Measured: Baseline, and 5 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 201613 Oct 2017

First posted3 Oct 2016 (estimated)
Study start23 Aug 2016
Primary completion21 Sep 2017
Study completion13 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for EndometriosisStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 60 participants (actual)
Target duration: 7 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT02921763
Sponsor's protocol ID: DUPKST16002
Status last verified: Jun 2022
First submitted: 13 Sep 2016
Last updated: 6 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: We will consider after completion of CSR

Publications

Kitawaki J, Koga K, Kanzo T, Momoeda M. An assessment of the efficacy and safety of dydrogesterone in women with ovarian endometrioma: An open-label multicenter clinical study. Reprod Med Biol. 2021 Jun 4;20(3):345-351. doi: 10.1002/rmb2.12391. eCollection 2021 Jul.
PubMed 34262403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Endometriosis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duphaston® Tablets 5 mg - A Survey on Efficacy and Safety in Patients With Endometriosis
ClinicalTrials.gov ID: NCT02921763
Acronym / sponsor ID: DUPKST16002
Conditions: Endometriosis
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Mylan Inc.Industry (pharma, biotech, devices)
Study start: 23 Aug 2016 (actual)
Primary completion: 21 Sep 2017 (actual)
Study completion: 13 Oct 2017 (actual)
First posted: 3 Oct 2016 (estimated)
Results: Posted 13 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 7 Months
Number of arms: 1

Arm	Type	Receives
Dydrogesterone	–	Drug: DydrogesteroneDydrogesterone 20 mg (4 tablets) per day should be orally administered in 2 divided doses (in the morning and evening). It should be administered for 21 days; dosage starts on the 5th day of each menstrual cycle until 25th day. The administration period will be from the start of Duphaston treatment (cycle 1) to cycle 4.

Who may qualify

Ages: 20 to 49 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: The subjects of the survey will be patients with a diagnosis of endometriosis.

Key inclusion criteria (3 listed)

Women aged 20 to < 50 years
Subjects with a chocolate cyst of the ovary measuring 3 cm in diameter on transvaginal ultrasonography at patient enrollment
Subjects with a menstrual cycle of 25 to 38 days who ovulate and are confirmed to have normal menstruation at patient enrollment

Key exclusion criteria (15 listed)

Subjects who used GnRH agonists within 6 months before patient enrollment
Subjects who utilized hormone preparations containing corpus luteum hormone or estrogen as an active ingredient, low-dose contraceptive pills, middle-dose contraceptive pills, testosterone derivatives, or herbal products indicated for endometriosis within 3 months before patient enrollment
Subjects who received surgical treatment for endometriosis such as transvaginal alcohol fixation, laparotomy or laparoscopic surgery within 2 months before patient enrollment
Subjects who are pregnant or may possibly be pregnant at patient enrollment
Subjects who are in breast feeding at patient enrollment

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
DydrogesteroneAlso: Duphaston	Drug	Dydrogesterone

Primary outcome

Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume)
Time frame: Before treatment initiation (baseline), 3 months, and 5 months.
In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: [(D1 + D2) × 1/2]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner. The change rate within ±15% from the total volume measured before treatment was defined as "unchanged," and the rate out of this range was defined as "decreased" or "increased."
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume)
Time frame: Before treatment initiation (baseline), 3 months, and 5 months.
In measurement of ovarian chocolate cyst, on a section visualizing the maximum diameter, two radial directions, namely the maximum diameter (D1) and maximum diameter (D2) orthogonal to D1, will be measured. A chocolate cyst of the ovary will be deemed as a spheroid, and its volume will be calculated using the following formula: [(D1 + D2) × 1/2]3 × 0.52 (π = 3.1). If there are two or more chocolate cysts of the ovary, similarly, two radial directions (D1 and D2) of each cyst will be measured. Also, each of their volumes will be calculated in the same manner.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline
Time frame: Before treatment initiation (baseline), 3 months, and 5 months.
The absolute change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated. For the mean value of the absolute changes shown here, the mean value of the absolute changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the absolute change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the absolute change in 40 cases with the volume value at this time. The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the absolute change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5. For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.
Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline
Time frame: Before treatment initiation (baseline), 3 months, and 5 months.
The % change from baseline were calculated on an individual basis and these were totalled and means ± SD calculated. For the mean value of the % changes shown here, the mean value of the % changes of the cases that could be measured at each time point is calculated. In other words, of the 57 cases with the volume value of baseline, Cycle 3 calculates the mean value of the % change in 39 cases with the volume value at this time, and Cycle 5 calculates the mean value of the % change in 40 cases with the volume value at this time. The remaining 18 cases are excluded from this calculation because there is no volume value for Cycle 3 and the % change from baseline cannot be calculated. The same applies to the 17 cases of Cycle 5. For this reason, these values cannot be calculated directly from the volume mean value at each time point shown in the result measurement 2.

8 secondary outcomes

Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score)
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change in Serum CA125
Time frame: Baseline, and 5 months.
Change Over Time in Dysmenorrhea Score (Total of the Dysmenorrhea Severity Score and the Analgesic Use Score), Difference From Baseline
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Difference From Baseline
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change Over Time in Visual Analogue Scale (VAS) for Dysmenorrhea, Change Rate From Baseline (%)
Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, and 5 months.
Change in Serum CA125, Difference From Baseline
Time frame: Baseline, and 5 months.
Change in Serum CA125, Change Rate From Baseline (%)
Time frame: Baseline, and 5 months.

Results and safety

Results posted to the registry on 13 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dydrogesterone	60	42

Primary outcome: Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume)

Time frame: Before treatment initiation (baseline), 3 months, and 5 months.. Count of participants. Unit: Participants

Measure	Dydrogesterone n = 52
Decreased	26
Unchanged	13
Increased	13

Dydrogesterone: p =0.0533, Sign test

Population analysed: 57 subjects were included in the efficacy analysis set. Of 57 subjects in the efficacy analysis set, changes in the volume of ovarian chocolate cyst before and after treatment in 52 subjects with values before and after Duphaston treatment.

Primary outcome: Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume)

Time frame: Before treatment initiation (baseline), 3 months, and 5 months.. Mean (Standard Deviation). Unit: cm^3

Measure	Dydrogesterone n = 57
Cycle -1	45.76 (40.70)
Cycle 3	51.97 (50.20)
Cycle 5	60.27 (109.04)

Population analysed: Of the safety analysis set (59 subjects), 57 subjects were included in the "efficacy analysis set," after excluding twe subjects (reason: one subject, use of concomitant medication indicated for endometriosis; one subject, violation of entry criteria).

Primary outcome: Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), Absolute Change From Baseline

Time frame: Before treatment initiation (baseline), 3 months, and 5 months.. Mean (Standard Deviation). Unit: cm^3

Measure	Cycle 3 n = 39	Cycle 5 n = 40
Value	0.04 (24.91)	8.48 (83.69)

Cycle 3: p =0.7328, Wilcoxon (Mann-Whitney)
Cycle 5: p =0.1193, Wilcoxon (Mann-Whitney)

Primary outcome: Volume of Ovarian Chocolate Cyst Over Time (If There Are Two or More Cysts, a Total Volume), % Change From Baseline

Time frame: Before treatment initiation (baseline), 3 months, and 5 months.. Mean (Standard Deviation). Unit: percent change

Measure	Cycle 3 n = 39	Cycle 5 n = 40
Value	3.97 (46.06)	-6.40 (86.88)

Cycle 3: p = 0.7221, Wilcoxon (Mann-Whitney)
Cycle 5: p = 0.0861, Wilcoxon (Mann-Whitney)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE information during the survey was collected during a period from the start of Duphaston treatment to the end of the observation period or discontinuation. Approximately 5 months in the study completers.(From date of dosage start, up to 5 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dydrogesterone	1 of 59 (1.7%)	7 of 59 (11.9%)	0 of 59

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34262403Kitawaki J, Koga K, Kanzo T, Momoeda M. An assessment of the efficacy and safety of dydrogesterone in women with ovarian endometrioma: An open-label multicenter clinical study. Reprod Med Biol. 2021 Jun 4;20(3):345-351. doi: 10.1002/rmb2.12391. eCollection 2021 Jul.
Individual participant dataSharing planned: Undecided. We will consider after completion of CSR

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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.

Jo Kitawaki, MD., PhD. principal investigator

Kyoto Prefectural University of Medicine

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by Mylan Inc. at 15 sites in Japan.

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 3 inclusion and 15 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 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in the Volume of Ovarian Chocolate Cyst (If There Are Two or More Cysts, a Total Volume) (time frame: Before treatment initiation (baseline), 3 months, and 5 months.). The study lists 4 primary outcomes in all. 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 NCT02921763, 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 6 Jul 2022.